Comments Off on How To Assemble Hoses And Seals With P-80® Temporary Rubber Lubricants
Cars, trucks, buses, locomotives, motorcycles, boats, airplanes, refrigerators, dishwashers, washers and dryers, pumps, construction equipment, conveyor belts, cable assemblies, and machines…What do all of these familiar items have in common?
All of them are composed of countless rubber parts that help them function properly and efficiently. Have you ever considered all of the uses for rubber hoses and seals? Without hoses, seals, grommets, O-rings and so many other rubber parts, most everyday items would leak, fall apart or otherwise malfunction.
Since rubber parts play such an integral role in product function and design, manufacturers have to be careful to assemble them properly to avoid problems down the line. While this sounds simple enough in theory, the reality is that assembling rubber parts can be quite difficult.
The slip-resistant nature of rubber makes it difficult to install, cut, remove or manipulate. Improper part alignment or installation can lead to part failure and safety issues. Repair and installation of rubber parts can take considerable physical effort and time.
Temporary assembly lubricants help solve this problem. When applied to rubber parts, temporary assembly lubricants reduce friction during assembly to make installation easier. Once dry the slipping action goes away and parts stay in place.
What is the best way to apply temporary lubricants to rubber parts? Brushing, sponging, spraying, dunking and dipping are all effective manual application methods. Since each assembly process is unique, the best method is often based on personal preference.
Watch this short video for International Products Corporation’s (IPC) suggestions for assembling hoses and seals with P-80® temporary assembly lubricants:
P-80 temporary assembly lubricants are water-based and do not contain alcohol or petroleum distillates, so they will not cause rubber to swell, dry out or harden. And, they do not contain silicon or other persistent ingredients, so once dry the slipping action goes away and parts stay in place. P-80 lubricants are free of hazardous ingredients, making them safe for workers and the environment. Most P-80 products are biodegradable.
Comments Off on Reclaiming Water To Maintain Future Economic Growth
How do you provide a consistent, high quality supply of water when you have a large volume ethanol distiller located in your backyard? The city of Fargo, ND came up with the perfect solution: reclaim water through the municipal wastewater treatment plant!
The wastewater treatment plant in Fargo, North Dakota has an auxiliary effluent re-use facility constructed specifically to produce reverse osmosis quality water destined for ethanol production. A local corn to ethanol distiller, Tharaldson Ethanol, requires approximately 1,000,000 gallons (3.8 million liters) of reverse osmosis water per day above the wastewater treatment plant’s normal processing volumes. Fargo’s wastewater control systems manager, Jeff Hoff, manages the effluent re-use facility to ensure this additional volume is met on a daily basis.
A key component of the effluent re-use facility is the ultra-filtration process, which uses 0.4μ polyvinylidene difluoride (PVDF) membranes with an upper pH limit of 10.0. These membranes are fouled primarily with petroleum sulfonates and bacterial secretions. Particularly in cold weather, the upstream BOD step has frequent “upsets,” where the bacteria die and secrete a water soluble foulant that adheres strongly to the PVDF polymer and significantly increases the trans-membrane pressure (TMP). These “upsets” must be resolved quickly to ensure a plentiful supply of pure water.
In order to determine the optimal cleaning regimen to resolve these upsets, Jeff systematically evaluated the performance of twenty different cleaners and hundreds of different combinations and concentrations, including commonly used commodities and many formulated membrane cleaners.
Jeff discovered that Micro-90®, a formulated cleaner from International Products Corporation (IPC), stood out because it performed better than all of the commodities and other formulated membrane cleaners, particularly on the bacterial secretions. What Jeff found most impressive is that this formulated cleaner worked effectively without the use of phosphates, silicates, and strong alkalis, at a membrane compatible pH of only 9.5, and at a 0.3 percent concentration.
Micro-90® is a mild, yet powerful, multipurpose, alkaline cleaning concentrate that is used for membrane cleaning as well as in laboratories, industrial applications, and critical cleaning processes. A unique chelating detergent, Micro-90® contains anionic and non-ionic ingredients which combine to produce a variety of cleaning actions. Micro-90® is compatible with UF, RO, Ceramic and NF Systems.
The Long-Term Success
This same formulation has been in use at Fargo’s effluent re-use facility since October 2010. Some of the original PVDF membranes are still used and continue to see significant TMP drops after cleaning. Although the bacterial upsets cannot be prevented, their fouling can be resolved in a predictable manner with the use of this formulated product.
The engineers at the facility recognize that using Micro-90® for regularly scheduled preventative maintenance and cleaning of the membranes proves to be an effective, safe, and economical method of keeping the plant running efficiently and the water flowing continually. Based on its effectiveness, safe profile, compatibility and economical cost per use, they have recommended Micro-90® to design engineers at similar effluent re-use facilities.
Comments Off on How Can You Help Customers Install Your Parts? P-80® To The Rescue!
Did You Know? P-80 Fun Facts…
Major manufacturing companies have used P-80 lubricants for years for the assembly of engine mounts, bumpers, seals, belts, bushings, O-rings, hoses, grommets, grips, plugs, moldings, tires and many other rubber or soft plastic engineered parts.
Did you know that you can help your customers to easily install those same parts? Simply include a tube of P-80 along with the parts in replacement and repair kits!
The slip-resistant nature of rubber makes it difficult to install, cut, remove or manipulate. Improper part alignment or installation can lead to part failure and safety issues. Repair and installation of rubber parts can take considerable physical effort and time.
What is P-80?
P-80 temporary assembly lubricants reduce friction during rubber assembly to make it easier to install parts. They are water-based and do not contain alcohol or petroleum distillates, so they will not cause rubber to swell, dry out or harden. P-80 lubricants do not contain silicon or other persistent ingredients, so once dry the slipping action goes away and parts stay in place. And, P-80 lubricants are free of hazardous ingredients, making them safe for workers and the environment. Most P-80 products are biodegradable.
P-80 temporary assembly lubricants are available in six different water-based formulas, so you can find the product that’s right for your assembly needs. There are even two special formulas that are registered with the NSF as H1 lubricants approved for incidental food contact applications.
A Win-Win Solution
P-80 is available in re-sealable 10 mL tubes that are perfect for inclusion in kits for repair or replacement parts. Companies that include P-80 in kits have found that less damage occurs to their products during repair or installation, saving money in the long run. Their customers are happy because the installation of the part is much easier. Since the tube is re-sealable, it can be used multiple times after opening.
Many jobs can benefit from the reduced friction and increased safety provided by P-80 temporary rubber assembly lubricants. Use P-80 to install or replace seals, grommets, hoses, valves, belts, bushings, grips, bearings, boots, bumpers, engine mounts, fuel lines, moldings, O-rings, wire harnesses, sleeves, gaskets and tires. Any time you encounter rubber parts…P-80 can help!
Comments Off on The ABC’s of Cleaning Validation: A Simple Primer
What is Cleaning Validation?
Cleaning validation is used to ensure that a cleaning procedure removes all trace soils, cutting fluids, fingerprints, particulates and cleaning agents from surfaces in regulated processes. Any residue must be removed to a predetermined level of cleanliness. Cleaning validation processes protect against the cross-contamination of ingredients from one batch to another, ensure that surfaces or devices are free of residue prior to any further sterilization process, and assist in ensuring product quality.
Cleaning validation is required for use in industries following Good Manufacturing Practices (GMP) as outlined by the US FDA. Manufacturers in the pharmaceutical, medical device and food and beverage industries all use cleaning validation methods to ensure that their equipment is free of waste and that subsequent products manufactured on that equipment are not jeopardized by any remaining soils or soap residue.
FDA guidelines for cleaning validation require specific written procedures detailing how cleaning processes will be validated. These should include:
Who is responsible for performing and approving the validation
When revalidation is required
Analytical methods to be used
Documentation of the studies and results
A final conclusive report stating that all residues have been removed to the predetermined level
If any part of the cleaning process is changed, the cleaning validation process must also be updated.
Cleaning Validation Methods
Various analytical methods can be used to detect cleaner residues on equipment. Each method is unique to the specific cleaner used. Cleaner manufacturers should be able to provide detailed validation methods for their products.
Regulated industries rely, in most cases, on quantitative validation methods. Quantitative validation methods provide measurable and exact results, whereas qualitative validation methods involve more subjective methods, such as visual observations.
HPLC (High Performance Liquid Chromatography)
HPLC stands for high performance liquid chromatography. HPLC validation methods can pinpoint exact ingredients. This validation method uses pressure to force a solution through columns to separate, identify and quantify each of its components.
The columns are filled with a solid adsorbent substance. As the solution is forced through the column, each of its components reacts differently to this substance. This results in varying flow rates for each component in the solution. The sample solution is separated into its individual elements by the rate at which they flow out of the column.
Once the individual components of the sample solution are separated, various types of detectors can be used for identification. Some common detectors include:
CAD – charged aerosol detector
DAD – diode array detector
MS – mass spectrometry
HPLC validation methods separate liquids into their individual components. This information is then used to determine the level of residue of an individual component so that predetermined acceptable levels of cleanliness are met. HPLC is the most common type of quantitative cleaning validation method currently used.
TOC (Total Organic Carbon)
TOC stands for total organic compound. TOC validation methods detect carbon content in a tested sample. The results are not ingredient specific. The amount of carbon in the sample can come from any one of a number of varying sources including contamination, a dirty tank, testing equipment, ingredient residue or cleaner residue. The objective is that the overall results of TOC testing meet the predetermined acceptable levels. Results that exceed the predetermined levels are not acceptable.
UV VIS stands for ultraviolet visible spectroscopy. This detection method relies upon the absorption of light to quantitate chemicals at specific wavelengths. Sometimes, a chemical agent is added to the rinse water sample to make key ingredients visible. Chemicals absorb light differently at different wavelengths.
Methylene blue, for example, is routinely used to react to sulfonate surfactants and detect detergent residue. The intensity of the color is an indication of how much sulfonate remains in the sample.
In the illustration above, the fluid at the top of the tubes shows the water in the solution. The fluid on the bottom indicates the amount of chloroform in the test sample. As the concentration of Micro-90 increases, more sulfonate is being pulled out of the top water level by methylene blue and the methylene blue-sulfonate complex enters the bottom chloroform layer resulting in an increasing blue intensity.
UV VIS is an older technology and is not as used as often as HPLC.
The Role Of The Cleaner Manufacturer
Cleaning validation is a critical part of the manufacturing process in regulated industries. Validation methods must be developed, planned and included in the production method. Since cleaning validation methods are unique to the cleaner used, it makes sense to expect the manufacturer to provide support. By relying on the cleaner manufacturer for detailed validation methods, manufacturers in regulated industries can focus their resources on manufacturing and product development, saving a great deal of time and money.
Comments Off on 10 Things To Know When Choosing An Assembly Lubricant
What is a Lubricant?
A lubricant is a material that reduces the friction between two surfaces making it easier for them to move across each other. Lubricity measures the reduction of friction that results from using a lubricant. A higher percentage of lubricity indicates a greater reduction of force.
Dry force is the amount of force required to insert a part without using a lubricant. Lubricated force is the amount of force required to insert a part after applying a lubricant. A force gauge meter can be used to measure the force (in newtons) needed to insert a part.
A lubricant should be used any time you need to decrease the friction between two surfaces.
10 Things To Know When Choosing An Assembly Lubricant
1. Temporary or Permanent Lubrication?
Some lubricants provide ongoing lubrication to keep parts moving over and over again. Machinery that consists of parts that must continually move or slide across each other will benefit from using a permanent lubricant to ensure they are operating properly.
Other lubricants provide temporary lubrication, reducing the friction between two parts for a short amount of time. After drying, the lubricity provided by a temporary lubricant is gone and the two parts will no longer slide easily across each other. Temporary lubricants are used for assembly and repair applications.
Rubber materials, in particular, are extremely slip-resistant, making them inherently difficult to install, remove, or otherwise manipulate – even when wet. This creates a challenge during the assembly and repair of rubber parts that can result in problems such as ill-fitting, misaligned or damaged parts, rolling O-rings, uneven cuts or worker injury. Temporary assembly lubricants can help prevent these problems.
2. How Much Lubrication Do You Need?
Sometimes you need a lot of lubrication, sometimes just a bit. Different lubricants will reduce friction by varying amounts depending upon their viscosity. Find a formula that is right for your application.
3. What are the Advantages of Temporary Assembly Lubricants?
Reduce Installation Force:
A thin film of lubricant applied to a part fills in any gaps, holes, or spaces between two separate surfaces, allowing them to slide across each other. By reducing the surface tension between the two surfaces, rubber parts can slide into place easily.
Design Parts with Better Tolerances:
When a lubricant is included in the design control process, mated parts can have lower tolerances because the characteristics of the lubricant are considered. Partnering with a lubrication engineer ensures the optimal lubricant is selected before production goes live.
Improve Product Performance:
Improper part alignment can lead to part failure and safety issues. Taking into consideration lubrication properties like dry time, material compatibility, any interfering residue and environmental conditions, will ensure that mated parts will work as anticipated.
Increase Production Rates:
Paring the optimal lubricant with the right application technique speeds up production.
Help to Avoid Worker Injuries:
Assembly lubricants ease the installation process of many parts. An increase in lubricity, even by small amounts, is greatly appreciated by line operators required to maintain strict cycle times. Inferior lubrication quickly leads to fatigue, muscle strain, injuries and lost work time.
4. What is the Dry Time of Your Temporary Lubricant?
Some temporary lubricants dry quickly while others take longer to fully dry.
Quick drying lubricants are frequently used in assembly applications in which the parts undergo pressure testing or movement shortly after assembly. In these cases, it’s important to have the part firmly in place before the next step in the assembly process.
Other assembly applications may take longer or the parts may need to be manipulated a few times before the assembly is complete. In these instances, you may benefit from a slower drying temporary lubricant.
Yet, in other assembly operations, achieving maximum lubrication may be the primary goal and the dry time of the lubricant is less important.
Manufacturers of temporary assembly lubricants should be able to advise you about methods of slightly altering the dry time of their lubricants based upon the amount applied, the method of application, part tolerance, material porosity, and temperature.
5. Can Temporary Lubricants be Used With All Types Of Surfaces?
It’s important to check the compatibility of any chemicals that will come in contact with your parts and equipment. What types of surfaces are they made of? Ask the lubricant manufacturer if their product is compatible with the specific type of rubber, metal and/or plastic found in your parts and equipment.
Lubricants will be absorbed more quickly by porous rubbers, like Buna-N and EPDM, than by plastics and coated rubbers. You may want to choose a quicker drying formula for less porous surfaces.
6. How Will You Apply the Lubricant?
Think about your assembly process and the parts that will need a temporary lubricant. What type of application method will work best for your unique process? Common methods of application include dunking and dipping parts, using brushes, sponges and sprays, and using automated solutions. Make sure the lubricant you choose will work well with the best application method for your unique situation.
7. Can They be Used for Food Manufacturing Equipment?
Food and beverage manufacturing is a highly regulated industry. Therefore, all parts and processes, including any lubricants that are used, must comply with federal regulations and industry standards. Look for specially formulated assembly lubricants that are registered with the NSF as H1 lubricants approved for incidental food contact applications.
8. Are They Safe?
Avoid using lubricants that can cause rubber parts to swell or dry out, like alcohol or petroleum-based products. Look for a product that is compatible with the parts it will come in contact with.
Be sure to also consider the environmental impact of any lubricants you are using. Look for products that are non-hazardous and non-flammable, making them safe for workers and the environment. Many assembly lubricants are biodegradable.
Choose an assembly lubricant that will work well, yet meet all of your safety requirements and federal regulations.
9. Is it Possible to Arrange a Trial?
Many lubricant manufacturers will offer free samples for testing. Testing enables you to run trials for your unique assembly application and choose the product that will best meet your needs.
10. Will the Manufacturer Offer Support?
In addition to their willingness to offer free product samples for testing, look for a supplier that can offer technical guidance and provide a variety of products to solve your assembly requirements. The manufacturer should be able to assist you by providing material compatibility studies, insertion force measurement testing, toxicology reports, regulatory compliance, free product samples, and technical support.
With careful thought and planning, you can find a lubricant that meets all of your specifications. When choosing a lubricant for your assembly application consider the amount of lubricity required, surface compatibility, dry time, application methods, chemical composition and safety of the product.
Comments Off on Guidelines For Cleaning Pharmaceutical Processing Equipment
Cleaning pharmaceutical processing equipment is challenging. Cleaning methods, soils present, type of manufacturing equipment, surfaces cleaned, choice of cleaning detergent and temperature should all be considered when setting up a cleaning procedure. Cleaning validation methods are required. The entire cleaning process must be standardized and documented according to the FDA’s cGMP regulations.
Why Clean Pharmaceutical Processing Equipment?
Maintain product quality.
Remove all trace ingredients to prevent the transfer of ingredients from one product to the next. This is especially important when multiple products are produced on the same equipment.
Prevent equipment malfunctions that may lead to product contamination.
Comply with local and international standards and regulations to ensure consumer safety and avoid legal issues.
Increase plant performance and productivity by diminishing waste, maintaining equipment and preserving product quality.
Enhance worker safety by providing a clean working environment and smoothly functioning equipment.
Establishing A Cleaning Procedure
Pharmaceutical manufacturers are required to set up a fully documented written cleaning procedure for each piece of processing equipment in compliance with FDA 21 CFR Part 211.67. Documentation should include:
Responsibility for equipment cleaning and maintenance
Cleaning and sanitization schedules
A detailed description of the cleaning procedure
Removal of previous batch identification
Protection of clean equipment
Inspection of equipment prior to use
Manufacturers must outline each of these steps in detail to be sure that all processes are followed clearly and succinctly.
Federal regulations require a very specific description of each step of the cleaning procedure. The following details should be documented.
Frequency of cleaning – including time requirements between processing products and cleaning
Cleaning tools used – any sponges, brushes, scrapers, sprayers, wipes or equipment used to aid the cleaning process
Establishment and sequence of each cleaning step
Identification of each specific piece of equipment to be cleaned, including instructions for cleaning between batches of the same or different products
Cleaning method – clean-in-place (CIP) or clean-out-of-place (COP)
Detailed instructions for any required disassembly and re-assembly of equipment if COP methods are used. Instructions should specify the parts to be removed and any assembly aids used during this process.
Identification of all cleaning detergents and detailed instructions for their use. Usage instructions should include amounts, concentration, temperature, dwell time and application method.
Soils found on pharmaceutical processing equipment may be traces of the various ingredients used in production or soils from the actual manufacturing process such as oil, grease, dust or minerals. Understanding the soils that are present will guide your choice of cleaning detergent.
Gels, polyethylene glycol, oils, titanium dioxide, dyes, silicons, flavorings, petrolatum, paraffin, proteins, steroids, sugars, alcohol, stearates, and cornstarch are some of the typical foulants that are often found on pharmaceutical processing equipment.
Each type of soil is unique and requires the proper detergent to thoroughly clean the surface. Choose a cleaner that will best attack the soils you are trying to remove. Alkaline cleaners are the best choice for cleaning soils such as gels, dyes and petrolatum, while citric acid based cleaners are better suited for removing titanium dioxide. Protein or starch-based soils may require the use of an enzyme cleaner. Use the table below to help match the most effective type of cleaner to each kind of soil.
Type of Equipment
Mixing tanks, tablet presses, capsule fillers, centrifuges, granulators, filling lines, mixers, conveyors, filters, fluid lines, batch process tanks, tubes and flasks all need to be thoroughly cleaned. The design of the equipment must be taken into consideration. By nature of its construction, some types of equipment will be more difficult to clean than others. Hidden parts and blind holes present unique challenges.
Another important factor to consider is the how the equipment is used. Are you cleaning a dedicated production system or equipment that is used to produce a range of products? Processing equipment used to produce multiple products has a greater chance of cross contamination of ingredients.
It’s also important to select a cleaner that is compatible with the surface of the equipment you are cleaning. The cleaner manufacturer should be able to guide you and provide compatibility studies for their products.
Cleaning Method and Location
Clean-in-place (CIP) or Clean-out-of-place (COP)?
CIP is generally used for large systems and components that cannot easily be taken apart. CIP often results in less downtime since it eliminates the need to take apart or move the equipment. Automated systems, spray systems and immersion are all examples of CIP operations.
COP is most often used for smaller pieces of equipment or smaller parts of larger equipment that can be removed and re-assembled after cleaning. COP can involve either manual washing or use of machine washers. Specific instructions for disassembling and re-assembling equipment must be followed.
What cleaning method will you use?
Manual, ultrasonic, spray, machine and automated systems are all used for cleaning pharmaceutical equipment. The type of cleaning method used will impact your choice of detergent. Automatic parts cleaners and high-pressure washers require low foaming detergents.
In most cases, increasing the temperature is one of the best ways to speed up or improve the cleaning action. The temperature parameters that should be used for any individual cleaning application will depend upon the equipment and the soils that are present, as well as your choice of detergent and wash method. Check with the manufacturer for the maximum suggested operating temperature for your detergent.
The length of the cleaning cycle contributes to the effectiveness of your cleaning application. In most cases, a longer dwell time will improve the results. However, all factors – soils, temperature, substrate, detergent and cleaning method must be taken into consideration.
Thorough rinsing should follow cleaning. Rinsing removes any excess detergent left on the item. For critical cleaning applications, it is best to use deionized or distilled water, as rinsing with ordinary water may introduce new contaminants.
Cleaning validation is a part of the regulatory compliance process for cleaning pharmaceutical processing equipment. Validation ensures that all equipment is washed according to previously determined standards and that all traces of soil and detergent are removed. Validation methods are unique to each detergent and should be available from most cleaner manufacturers.
Need help choosing the right specialty cleaner for your pharmaceutical cleaning application? Contact one of International Products Corporation’s (IPC) technical specialists or request a free cleaner sample for testing. All of IPC’s specialty cleaners are registered with NSF as A1 cleaners and can be validated in FDA processes.
Comments Off on Save Time And Money With Preventative Maintenance
It’s summer! It’s time to relax and enjoy the warmer weather. Kids are out of school, daylight hours are long, families flock to beaches and it seems like just about everyone takes a vacation.
While summer means various things to different people, for many manufacturers summer means factory shutdowns, plant retooling and scheduled maintenance operations.
What is Preventative Maintenance?
We’ve all been there. Any of these scenarios ring a bell? A long road trip and your car won’t start. You’re hosting Thanksgiving dinner and your oven isn’t working. Or, it’s the worst heat wave of the summer and your air conditioning unit dies. Regardless of the scenario, we can all agree that malfunctioning equipment is extremely aggravating. If only there were a way to prevent these things from happening!
While we can’t prevent all unplanned breakdowns, there are actions we can take to minimize their occurrence. That’s where preventative maintenance steps in. Preventative maintenance refers to regularly scheduled maintenance operations designed to keep equipment functioning optimally throughout the year to help prevent unplanned breakdowns.
Similarly to taking your car to the shop for regular oil changes or servicing your air conditioning unit annually prior to the summer heat, manufacturing plants can take steps to regularly inspect and service their equipment to help prevent costly and untimely breakdowns.
Why Should You Perform Preventative Maintenance?
Simply put, preventative maintenance saves you time and money. Equipment breakdowns are costly and inconvenient. Depending on its function, one piece of malfunctioning equipment can bring an entire plant to a grinding halt leading to lost production and expensive repairs.
Isn’t taking a piece of equipment out of commission to perform preventative maintenance equally as time consuming and expensive? Absolutely not! Sure, maintenance tasks take time and cost money, but planning for them minimizes the bite.
Would you prefer to take your equipment out of commission during a slow period or on your busiest day of the year? Imagine the oven at your local pizzeria breaking down on Super Bowl Sunday. There’s no way to recoup those lost sales!
Parts and labor almost always cost less when it isn’t an emergency repair situation. Having spare parts shipped overnight is not cheap! And, finding service personnel who can drop everything and come right away isn’t always a reality.
Many manufacturing plants shut down for a short time during the summer for retooling in preparation for new production runs. Planning preventative maintenance to coincide with scheduled plant shut downs is a win-win.
7 Benefits of Preventative Maintenance
Increase equipment life
Improve functionality and reliability of equipment
Decrease unplanned breakdowns
Less costly repairs
More productive operations
Maintain product quality
Reduce risk of worker injury
The expression “the best offense is a good defense” perfectly sums up the principle of preventative maintenance. Advance planning keeps costs down and helps keep your equipment running smoothly and efficiently.
Setting Up A Preventative Maintenance Plan
Obviously, every manufacturing plant is unique and each one may have distinct maintenance needs. But, universal considerations that come into play when setting up a preventative maintenance plan include frequency, responsibility, identification of specific tasks and monitoring of the process.
How often should equipment be inspected and repaired? This will depend upon your industry and the type of equipment. Scheduled maintenance is often based upon time intervals, equipment usage, or specific trigger events.
Time triggers are based upon specific calendar intervals. Do you inspect and service the pumps in your plant every three months? Or, do you check the antifreeze in your vehicle prior to the onset of cold weather? Similar to your annual physical with your physician, time triggers are maintenance activities based upon the passage of specific periods of time.
Usage triggers are based upon how and when the equipment is used. Examples of usage triggers are changing the oil in your car every 5,000 – 10, 000 miles, or cleaning the processing lines and tanks in your manufacturing plant after each production run.
Event triggers are marked by equipment performance. In wastewater treatment facilities, filter membranes are often cleaned when their flux rate drops by 10 percent. Other examples of event triggers are sharpening a knife when it becomes dull or filling your car tires with air when the pressure drops below a specified level.
Who is responsible for performing scheduled maintenance services? Are the drivers and technicians that use the equipment expected to perform preventative maintenance activities? Or does your facility have a specified maintenance team that inspects and repairs equipment on a regular basis? It’s important for the entire team to know who to go to for regular upkeep of their equipment.
Identify specific maintenance tasks
What maintenance operations should be conducted on a regular basis? Not only will this vary based upon your equipment and your industry, but it may also differ from one plant to another. A checklist of each and every preventative maintenance task should be developed and followed. Common maintenance tasks may include inspecting and testing functionality, cleaning equipment and replacing parts.
All maintenance activities should be recorded and tracked. This helps in planning future maintenance schedules, estimating and keeping track of costs, and monitoring equipment safety and functionality. Most companies use software designed for this purpose, but manual records can also be used.
When things are running smoothly it’s easy to overlook common maintenance chores and rationalize that it’s not worth the time to regularly inspect and repair parts. But nothing could be further from the truth. Proper maintenance helps ensure that your equipment is working correctly and your facility is functioning efficiently. Investing the time and money to set up and follow a regular maintenance plan will provide long-term savings by keeping your business functioning smoothly and efficiently.
Need help getting started setting up a preventative maintenance plan for your facility? IPC’s temporary assembly lubricants and specialty cleaners are routinely used in preventative maintenance programs. Read more industry specific guidelines here:
Comments Off on How to Properly Clean Medical Devices
When it comes to medical devices cleanliness is crucial. All medical devices, whether they are disposable, implantable or reusable, must be cleaned during the manufacturing process to remove oil, grease, fingerprints and other manufacturing soils. Reusable products must also be thoroughly cleaned and sterilized between each use to avoid infecting patients or causing illness. Reaching the right level of cleanliness does not come automatically. A well planned cleaning regimen must be developed and followed carefully.
Developing a Cleaning Process
Medical device manufacturers must provide proof that their products can be adequately cleaned as part of the FDA approval process. As a result, most manufacturers now incorporate setting up a cleaning protocol as part of the design and development phase.
Factors to consider when setting up a cleaning regimen:
Soils: Choose a cleaner that will best attack the soils you are trying to remove. Enzyme cleaners are often used for medical device cleaning applications since they work well at removing organic soils. Protease enzymes in particular are a good choice for protein based organic soils like blood, fat, sweat, mucous, feces and tissue.
Surface: Titanium, plastic, ceramic, silicone and metal are some of the more common materials used in the manufacture of medical devices. It’s important to select a cleaner that is compatible with the substrate of the device you are cleaning. The cleaner manufacturer should be able to guide you and provide compatibility studies for their products.
Wash method: Common methods of cleaning medical devices include automatic washers, ultrasonic cleaners and manual washing. Factors such as soil, substrate, composition and end use of the device are taken into consideration. Regardless of the method used, it’s extremely important to be sure that all soils are removed from blind holes and internal passages of the device.
Temperature: In most cases, increasing the temperature is one of the best ways to speed up or improve the cleaning action. The temperature parameters that should be used for any individual cleaning application will depend upon the make-up of the medical device and the soils that are present, as well as your choice of detergent and wash method. Check with the manufacturer for the maximum suggested operating temperature for your detergent.
Dwell time: The length of the cleaning cycle contributes to the effectiveness of your cleaning application. In most cases, a longer dwell time will improve the results. However, all factors – soils, temperature, substrate, detergent and cleaning method must be taken into consideration.
Rinse step: Thorough rinsing should follow cleaning. Rinsing removes any excess detergent left on the item. For critical cleaning applications it is best to use deionized or distilled water, as rinsing with ordinary water may introduce new contaminates.
Validation procedures: Cleaning validation is a part of the regulatory compliance process for medical device manufacturing and reprocessing. Validation ensures that medical devices are washed according to previously determined standards and that all traces of soil and detergent are removed. Validation methods are unique to each detergent and should be available from most cleaner manufacturers.
Medical devices not only need to be clean, they also need to be sterile. Medical devices that are not properly cleaned and sterilized can lead to patient infection. Cleaning and sterilization are two distinct processes and both must be performed to ensure that medical devices meet safety standards.
The CDC defines cleaning as “the removal of foreign material (e.g., soil, and organic material) from objects…normally accomplished using water with detergents or enzymatic products”. (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html). They describe sterilization as a process that “destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item”. (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/index.html). The CDC has established guidelines that are used to determine if a medical device is considered sterile. This is referred to as the sterility assurance level or SAL of a product and is defined as the likelihood that any viable microorganisms will exist on a device after sterilizing.
Why do Both?
Clearly we have two different, albeit related, processes. So, why do both? Cleaning the medical devices first ensures that they are free from soils and debris that can cause infection and reduce the efficiency of the sterilization process.
The CDC guidelines explain that “Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective.” (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html).
If a surface is sterilized or disinfected before it is cleaned, the remaining soils can still contribute to the growth of harmful germs and lead to further contamination. Lingering soils on the surface of the medical device can serve as a barrier and impact the efficiency of the sterilization process. If the surface is thoroughly cleaned first, and validated for cleanliness, sterilization is much more effective.
Interested in learning more about choosing the right specialty cleaner for your medical device cleaning application? Contact one of International Products Corporation’s (IPC) technical specialists or request a free cleaner sample for testing. All of IPC’s specialty cleaners are registered with NSF as A1 cleaners and can be validated in FDA processes.
Comments Off on How do I Choose the Best Detergent for My Cleaning Application?
It’s easy to see that you have a dirty surface that needs to be cleaned. Figuring out what type of cleaner to use can be tricky! Choosing the right product from the outset will make your cleaning task easier, quicker and more efficient. So, how do you know which detergent to use?
Dirt is Dirt, Right?
Absolutely not! All soils are different and need to be treated properly. A detergent that works well for cleaning grease and oil might not be the best choice for getting rid of soap scum or starchy soils. While some cleaners may work well for a broad spectrum of soils, others may be needed to target specific types of dirt.
Alkaline cleaners work well for organic soils like oils and grease, while acid based cleaners are more effective on inorganic soils such metals and salts. Knowing what type of soil you are dealing with is an important step to choosing the right detergent.
This helpful chart matches detergents to soils commonly found on parts and equipment in laboratories, pharmaceutical plants, food & beverage manufacturing sites, medical devices, filter membranes and manufacturing facilities.
What are You Cleaning?
Glass? Metal? Rubber? Electronic parts? Filter membranes? Understanding how different detergents affect different surfaces will certainly have an impact on your choice of cleaner. It’s important to be sure that the detergent you are using is compatible with the surface you are cleaning.
The manufacturer of the cleaner should be able to provide you with compatibility information for the product you are using.
How are You Cleaning?
The cleaning method you plan to use also plays a role in choosing a detergent. Some of the more common methods used in manufacturing and laboratory applications include:
• Ultrasonic cleaning
• CIP (clean-in place)
• Manual or hand wash
• Automatic washers
It’s important to choose a detergent that works well for your chosen cleaning method. For example, if you are using an automatic washer it’s wise to use a low foaming cleaner. Otherwise you may end up with a room full of foamy suds. While this is great fodder for TV sitcoms, it’s not so funny in real life.
Is Your Cleaner Safe?
There are many cleaners on the market that do a great job at removing dirt, but they contain solvents and other harmful ingredients. Look for cleaners that are both effective and safe. Many cleaners are biodegradable. Try to avoid products that contain phosphates, solvents, silicates, phenols, and substances of very high concern.
International Products Corporation’s (IPC) cleaners are safe for personnel, materials, equipment and the environment. Yet, they are powerful enough to remove the most difficult soils. This makes them excellent alternatives to hazardous solvents and chemicals frequently used for precision cleaning applications.
The Manufacturer Matters
When you select a product for your critical cleaning application you should be equally as concerned with the support provided by the manufacturer as you are with the product performance.The benefits of working with an experienced specialty cleaner manufacturer are that they can offer technical guidance and provide a variety of products to best meet your needs. Cleaner manufacturers should be able to assist their customers by providing validation methods, compatibility studies, toxicology reports, regulatory compliance, free product samples, and technical support.
There are so many variables that exist in choosing the right cleaning product. Remember to consider the soils, the surfaces, the cleaning method, the safety and the manufacturer. With careful thought and planning you can find a cleaner that meets all of your specifications. Choosing wisely makes a difference!
Download IPC’s ePaper for more information about choosing a cleaner and establishing the right cleaning parameters.
Comments Off on Solve Hydraulic Line Assembly Problems With P-80® THIX
A worldwide crane manufacturer experienced hydraulic system issues, including contamination, rolled O-rings, leaks, and line shut-downs resulting from numerous false-positive leak detections. Once they began using P-80® THIX for assembly they were able to eliminate false positive hydraulic leaks and contamination, allow easier thread starts and aligned joint assemblies, and achieve torque specifications.
What is P-80® THIX?
P-80 THIX is a biodegradable temporary assembly lubricant that eases installation of tight-fitting rubber and plastic parts by reducing the force needed for insertion. Once assembly is complete, the lubricant dries and the part stays in place. Since THIX is a water-based, thixotropic gel, it stays where it’s put without dripping. THIX does not contain any alcohol or petroleum distillates, so it will not cause rubber to swell, dry out or harden, nor does it contain any hazardous ingredients, making it safe for workers and the environment.
What Was Happening at the Crane Manufacturer’s Plant?
The crane manufacturer was using multiple petroleum-based lubricants for the assembly of hydraulic hoses and thread starts. These lubricants eased the assembly of the hydraulic lines and facilitated thread starts, but, if not applied meticulously, slowed production, increased cost of quality, and increased the amount of rework needed. Over-application of these lubricants caused residue to remain in and around hydraulic lines attracting dirt, contaminating hydraulic systems, fluorescing brightly during black light leak inspections – leading to false positive results, and reducing installation torque over time. When used sparingly, the lubricants caused leaks from rough thread starts, rolled O-rings, friction-related damage, misaligned parts, and low installation torques. They also had frequent line shut-downs because of many false-positive leak detections.
P-80 THIX to the Rescue
A team of design engineers, material engineers and hydraulic line assemblers worked together to find a solution. P-80 THIX was trialed for assembly of hydraulic lines and coating of threads for wet torque starts.
Since THIX is a water-based emulsified thixotropic gel, the volume applied was not critical. Once applied, THIX remained in place regardless of the part’s orientation. The gel as a whole reduced assembly friction by 70% thereby eliminating rolled O-rings and misaligned parts. Installation torques were achieved consistently. After assembly, THIX began to evaporate and lose its lubrication – leaving at most a negligible residue, which will not attract dirt or contaminate the hydraulic system, will not fluoresce, and cannot reduce torque over time.
The crane manufacturer experienced an immediate improvement in cost of quality and on-time delivery metrics. As a result, THIX has been implemented throughout the entire assembly floor and is currently being trialed at other locations worldwide.