Comments Off on Best of 2018: IPC’s Top 5 Posts of the Year
As 2018 draws to a close, it’s time to take a look back at all that has happened over the past twelve months. This has been a very productive year for International Products Corporation and we look forward to continued growth during 2019.
We have embarked on a building renovation project and are expanding our warehouse to better serve our customers. Recently, we installed a new manufacturing filling line that provides for more efficient and quicker operations.
Throughout the year we exhibited at various trade shows and visited many of our customers and distributors worldwide.
Our on-site laboratory has worked on various customer driven research projects and continues to ensure the quality of our products.
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?…
The O-ring…the little part that plays a big role! “What are the parts of a car?” Most people will answer with “engine, thermostat, radiator, water pump, battery, alternator, ignition, steering wheel, tires, windows, doors, and seat belts”. Not too many people will mention O-rings…
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!…
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!…
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….
Did we miss your favorite post from 2018? Please let us know! We have more great content coming your way in 2019. Be sure to subscribe to the IPC blog to read the latest and greatest from the IPC team.
Happy New Year and Best Wishes for a wonderful 2019 from everyone at IPC!
During the month of December, most of us are busy shopping, cooking, decorating and attending parties. Our days are filled with finding the perfect gift for our loved ones, baking dozens of cookies and deciding upon the best outfit to wear to each holiday event. Hours are spent with our families trimming the tree, lighting a menorah or celebrating the seven core principles of Kwanza. Regardless of which holiday we celebrate, most of us are engaged in a multitude of seasonal activities.
It’s easy to get caught up in the hustle and bustle of the holiday season. But, it’s always important to remember those who may need a little help at this time of year. This year, the employees at International Products Corporation (IPC) have banded together to give back to our community and help our neighbors who may be struggling to provide their families with a happy holiday.
In celebration of the holidays, IPC employees have contributed to two worthwhile causes: Toys for Tots and The Foodbank of South Jersey. Employees have generously filled our donation boxes with an array of toys and food to help those in need.
The mission of Toys for Tots is to collect new unwrapped toys and distribute those toys to less fortunate children at Christmas. The primary goal of the program is to help bring the joy of Christmas and send a message of hope to America’s less fortunate children.
The Foodbank of South Jersey provides food to people in need throughout Burlington, Camden, Gloucester and Salem counties in NJ. Their mission is to make the holidays (and every day) hunger-free by providing nutritious, high-quality food to those who cannot provide for themselves.
All of us at IPC are grateful that we can celebrate with our families, showering our children with gifts and filling our tables with mouth-watering feasts. Knowing that our efforts may have helped less fortunate families feel that same joy is the best gift we can wish for this holiday season.
Comments Off on Ergonomics: A Winning Formula For Improved Quality, Safety And Production
International Products Corporation (IPC) recently upgraded their manufacturing facility with the installation of a 20-liter liquid filling line that not only provides for a quicker, more efficient manufacturing process but also provides ergonomic benefits for workers. The new station was engineered, manufactured and installed by Inline Filling Systems.
The new equipment has designated product capabilities and is used to fill 20-liter (5-gallon) sized containers of the company’s lubricants and cleaners.
Features of the new equipment include:
Increased Fill Accuracy
Increased Worker Safety
Assisted lift devices
Automatic speed adjustments
Automatic case erector
Ergonomic Improvements Are A Win-Win
Ergonomics Reduces Injuries
Worker injuries are frequently the result of repetitive movements and strain caused by moving heavy objects. Lifting, pushing and pulling heavy loads can all cause undue strain leading to injury. Ergonomic lifting equipment helps to eliminate the strain caused in these instances. The assisted lift device on IPC’s new fill line bears almost the entire weight of the heavy bottles.
Ergonomics Improves Quality
If line workers are in pain, tired or frustrated, the quality of their work may suffer. By installing ergonomic lifting equipment, the strain and repetitive motion of lifting are removed and workers can more easily focus on the task at hand. In addition to providing ergonomic benefits, IPC’s new filling line provides increased automation which reduces the likelihood of human error.
Ergonomics Increases Productivity
With ergonomic improvements in place, jobs can be completed with less strain and fewer motions leading to a quicker, more efficient production process. Adding to the ergonomic benefits, IPC’s new filling equipment has the capacity to fill three to four times the number of bottles as the equipment previously used.
Ergonomic improvements in the workplace are beneficial to companies and their employees. Improvements in quality, production and employee well being all contribute to reduced costs and a safer work environment. A win-win for everyone!
Comments Off on Keep Your Powersports Vehicle in Tip-Top Shape
Riding your motorcycle on a crisp fall day, feeling the wind on your face and seeing the colorful splendor of the autumn leaves, can be quite an exhilarating experience. Nothing can dampen that feeling more than having to cancel your ride because of a breakdown. Routine maintenance can help prevent unexpected repairs.
Powersports vehicles such as motorcycles, ATV’s, snowmobiles, scooters and personal watercraft should all undergo regular maintenance to keep them running in tip-top condition. Oil changes, tune-ups, chain adjustments, brake and safety inspections, engine maintenance and parts cleaning are all common scheduled maintenance tasks.
Why Should You Schedule Preventative Maintenance?
Routine maintenance helps keep your powersports vehicle running smoothly. Not only will regular cleaning and maintenance keep your vehicle looking great, it also gives you the opportunity to carefully inspect all of its parts to catch any issues before they become major headaches. Preventative maintenance can increase equipment life, improve the functionality and reliability of your vehicle, decrease unplanned breakdowns and allow for less costly repairs.
Cleaning Vehicle Parts Is A Key Maintenance Task
Cleaning older parts is one of the first steps in many repair and maintenance jobs. Refurbishing suspension components, chain lubrication and adjustments, rebuilding engines, brake repair, oil changes, carburetor cleaning, fluid flushing and safety inspections all begin with parts cleaning. Removing grease, oil and dirt from used parts makes them easier to inspect and repair.
What’s The Best Way To Clean Parts?
Parts washers are a great solution for cleaning vehicle parts and tools. Hand washing in hot water will get parts clean, but parts washers will provide a deeper, more thorough cleaning. Parts washers will gently move parts during cleaning which helps remove dirt and debris. Plus, when used with the right cleaning detergent, parts washers can remove dirt from blind holes and obstructed sections of equipment.
There’s a New Kid On the Block
Many shops struggle with finding an effective parts cleaner that is easy to use. ANSED Diagnostics recently introduced a new portable parts washer that is ideal for small motorcycle and auto repair shops, racing teams, bicycle shops and garage repair shops. This powerful unit generates its power from an air compressor, so no electricity is required. And, it only weighs 22 pounds making it easy to use and carry.
Simply attach the unit to any standard air compressor and fill it with water and LF2100 Liquid Low Foam Cleaner. Place the dirty parts into the liquid and turn on the air compressor. The cleaning solution will bubble and agitate providing deep cleaning to all the hidden areas of your parts. Be sure to use the low foaming cleaner included with the unit to avoid excess foaming during the cleaning cycle. When the cleaning is finished, turn off the air compressor, remove the parts and empty the liquid from the unit.
Putting It All Together
Once the parts are cleaned and serviced, it’s time to reassemble your vehicle. Using a temporary rubber assembly lubricant will help reduce the force needed to install rubber parts like O-rings, seals, hoses and bushings making the job go smoothly and efficiently.
Before you know it, you’ll be riding into the sunset on your newly cleaned and maintained bike.
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.