Tag Archive: specialty cleaners

  1. The Importance of Cleaning Before Disinfecting

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    Disinfecting surfaces to kill traces of microbes and disease is a critical concern right now. A common misconception is that simply disinfecting a surface is enough to sanitize it. This is not the case, cleaning and disinfecting are both important parts of a thorough sanitizing process.

    FoodBev photo 2

    Why do both?

    Surfaces must be properly cleaned prior to disinfecting. Removing traces of dirt, debris, and dust primes surfaces and equipment for disinfection. Soils can harbor germs and bacteria. Disinfection becomes less effective if surface soils are present.

    Clean.disinfect. table

    What happens if I disinfect without cleaning?

    If a surface is disinfected before it is cleaned, the remaining soils can still contribute to the growth of harmful microbes and lead to further contamination. The residual soils may also serve as a barrier, preventing the disinfectant from reaching the surface and doing its job. Lingering soils on the surface may affect the active chemicals in a disinfectant, impacting their efficiency. If the surface is thoroughly cleaned first, and validated for cleanliness, the disinfection step becomes much more effective.

    What are the steps for proper cleaning and disinfecting?

    1. Remove large debris
    2. Surface rinse with potable water
    3. Clean with a specialty detergent like Micro-90® or Micro® Green Clean
    4. Rinse thoroughly with potable water
    5. Disinfect
    6. Rinse again
    7. For regulated industries, validate the cleaning process

    Contact IPC’s product specialists for more information about hard surface cleaners for manufacturing and laboratory applications.

    Request a sample for testing today! 

    i (IFAS 2015 http://www.edis.ifas.ufl.edu/fs077)
    ii (Safefood 360 2012 http://safefood360.com/resources/Cleaning.pdf).

  2. Selecting the Right Ultrasonic Cleaning Detergent for Regulated Industries

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    Regulated industries use ultrasonic cleaning for pharmaceutical equipment, medical devices, surgical equipment, labware, optical instruments, and dental equipment because it is highly effective at removing soil and debris before sterilization, especially on intricate or hard-to-reach parts. A detergent must be used in conjunction with ultrasonic cleaning in order to effectively remove most soils. A multipurpose cleaner is ideal because of its versatility.

    3 Things to Consider When Selecting the Right Detergent for Your Ultrasonic Cleaner

    1. What are the Soils?

    Understanding which soils you need to remove will guide you in choosing the right detergent. Micro-90®  is an alkaline cleaner that is designed to work well on a broad spectrum of soils. It is extremely effective for removing oil, grease, wax, tar, flux, particulates, and biological debris.

    2. What are the Substrates?

    Choose a cleaner that is compatible with the surface you are cleaning. Micro-90 is a safe for use on most metals, elastomers, plastics, ceramics, and glass surfaces. Samples are available for compatibility testing.

    3. Safety and Environmental Impact

    Most commercial critical cleaners are effective in removing dirt, but many are also corrosive, harmful if inhaled, and environmentally hazardous. Safer cleaning detergents will be free of phosphates, solvents, silicates, phenols, and substances of very high concern.

    View this video to see the effectiveness of Micro-90 in ultrasonic cleaning.

    Using Micro-90 in Ultrasonic Cleaning

    Micro-90 is a multipurpose, alkaline concentrate that provides superior performance in ultrasonic cleaning. The ingredients in Micro-90 penetrate tough oils and greasy films, allowing the soil to become suspended in the solution without the risk of redepositing. These properties make Micro-90 just as effective as corrosive cleaners without the health or environmental risks. Micro-90 does not contain solvents, phosphates, or heavy metals. In fact, Micro-90 removes hard metals in water that would otherwise detract from the detergency of the solution.

    The ingredients in Micro-90 were chosen for easy validation in an FDA process. Reports can be provided upon request. It is also NSF registered as a USDA-A1 Cleaner. Micro-90 can be used in concentrations as low as 0.5% up to 5%, and concentration can be easily determined by conductivity. Micro-90 has a high cloud point, making it easy to see when parts are clean. When properly rinsed, Micro-90 leaves no residue.

    Try Micro-90 in your ultrasonic cleaning unit. Request your free sample!

  3. Save Up to 60% by Switching to 20-Liter Pails

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    Do you know how economical it is to purchase IPC’s lubricants and cleaners in bulk? Depending on the product, you can save as much as 60% off list price when you switch to a 20-liter pail. Savings may also be realized in reductions in product cost, packaging cost, and shipping cost. Many of International Products Corporation’s (IPC) customers buy their P-80 lubricants and specialty cleaners in 20-liter pails for these reasons.

    Reduce Environmental Footprint

    In addition to reducing cost, buying larger sized containers is also better for the environment. Less plastic or other raw materials are used to make the containers, labels, and packing materials. Ordering larger sized containers may mean the company needs to order less frequently, so fewer resources are used during transport.

    The size of the 20-liter pail may seem daunting to some, but opening and handling it can be quick and easy.

     

    5 Easy steps for Opening and Dispensing From a 20-Liter Pail

    IPC ships all 20-liter containers inside an outer box for additional protection. Product labels are affixed to both the outer box and the plastic pail for easy identification. Each container is shipped with a plastic faucet that is used for dispensing.

    1. Unscrew the cap

    A wrench is helpful to loosen the cap for removal. We recommend a w397 Rieke70mm screw cap tightening tool. The diameter of the wrench is 3 inches.

    2. Remove the center covering

    Once the cap is removed, the center covering of the cap must be opened so material can be dispensed via the faucet. This covering can be removed with a utility knife or a hacksaw.

    3. Screw in the faucet

    After the hole in the center of the cap is removed, you can screw in the faucet securely. The lever to the faucet controls the flow of material from the container.

    4. Turn container on its side

    The container can be turned on its side to easily control the spigot and dispense material into another reservoir for use. When not in use for an extended period of time, we suggest you turn the container to the upright position.

    5. Use the lever to dispense

    Turn the lever on the faucet to dispense material into your smaller container. The small cap on top of the 20-liter pail can be used to control the air flow into and out of the container. If left closed, the material will flow from the faucet at a slow rate. To open, remove the cap and punch a small hole into the center of the valve. This can be done with an awl, knife or other sharp tool and a hammer.

    Download IPC’s step by step instructions for opening and dispensing from a 20-liter container here.

     

    Place an order here.

     

  4. International Products Corporation And The US Department Of Commerce Strategize For International Sales Growth

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    International Products Corporation (IPC) helps businesses worldwide ease assembly operations and keep facilities and equipment clean.

    Who is IPC?

    IPC is a specialty chemical company that manufactures safe, water-based, temporary rubber assembly lubricants and precision cleaners.

    P-80® temporary rubber assembly lubricants are designed to decrease the installation force needed to assemble rubber parts, improving worker safety and plant productivity.

    IPC’s full line of precision cleaning products includes biodegradable, alkaline, acidic, neutral, and enzymatic products used in a broad range of industries and applications.

    Key industries for both product lines include automotive, aerospace, appliance, pharmaceutical, food & beverage, medical device, pump, laboratory, manufacturing, membrane cleaning and wastewater.

    Where Is IPC?

    IPC’s head office and ISO: 9001 manufacturing facility are located in Burlington, NJ. All of IPC’s products are made in the USA.

    In 1984, IPC opened a subsidiary in the United Kingdom to serve the European market.

    Additionally, IPC has a network of foreign distributors to accommodate customers in many parts of the world.

    So yes, international isn’t just a part of our name…IPC is truly an international company.

    US Department Of Commerce Assists IPC For Further Global Growth

    IPC is one of more than 100 American businesses traveling to India as part of the U.S. Department of Commerce’s largest annual trade mission program, Trade Winds.

    This year’s Trade Winds’ focus is the Indo-Pacific region. The mission encourages U.S. based businesses to explore opportunities and develop strong business ties to India and other countries throughout the region.

    Trade Winds Indo-Pacific features a three-day business forum in New Delhi, India with optional trade mission stops in Ahmedabad, Chennai, Kolkata, Mumbai, Bengaluru, Hyderabad, Bangladesh and Sri Lanka. At each mission stop, attending companies will meet directly with government leaders, market experts, and pre-vetted potential business partners.

    IPC’s President, Kathy Wyrofsky, is “looking forward to connecting with prospects and customers with the support and assistance of the Trade Specialists at Tradewinds 2019”.  While IPC already has a presence in the region, Kathy is excited about joining this mission to create additional longstanding relationships with partners and companies in the region.

    What is Tradewinds?

    Trade Winds is the largest annual US Department of Commerce led trade mission. Since 2008, Trade Winds has delivered tangible bottom-line results in demanding markets all over the world. Now in its 11th year, Trade Winds has directly supported more than $3.4 billion in U.S. exports in over 40 countries. To date, Trade Winds has helped U.S. businesses conduct over 4,000 pre-vetted business-to-business meetings and over 6,000 government-to-business meetings around the world.

    Contact our product specialists to learn how IPC’s P-80 Temporary Rubber Assembly Lubricants and Specialty Cleaners can benefit your manufacturing facility. Whether you’re located right in our backyard or on another continent, IPC can help!

  5. Why Micro-90® is A Lab Tech’s Best Friend

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    What Is One Of A Lab Tech’s Biggest Challenges?

    Cleaning lab equipment, of course! Everyone knows that labware must be properly cleaned, but what’s the best way to achieve that goal? And, why is cleaning so important?

    Why Clean Lab Equipment?

    Regular cleaning is one of the easiest ways to keep your equipment functioning properly. Apparatus that is not thoroughly cleaned can yield inaccurate and inconsistent results. Trace ingredients from previous use must be removed to avoid cross-contamination and to ensure that all future test results are error-free.

    Proper maintenance of labware and apparatus helps to ensure that your equipment is working correctly and your lab is functioning efficiently. Analyzers, centrifuges, microscopes, pipettes, beakers, slides and flasks all need to be kept clean to provide accurate readings. Failure to properly maintain lab equipment can have a direct impact on test results.

    How To Set Up A Cleaning Regimen?  

    Since regular cleaning is one of the easiest ways to keep your equipment functioning properly, it’s important to establish a cleaning procedure and stick to it. The exterior surfaces of all equipment should be wiped down on a daily basis, after each use. A complete cleaning should be performed at least once a week.

    Consider these factors when setting up your cleaning process: 

    Download IPC’s 7-Step Guide to the Proper Use of Critical Cleaners for help in setting up your cleaning regimen.

    Selecting the right cleaner for your lab equipment is extremely important. There are many different kinds of products available, so it’s important to consider all of the above factors when making your decision.

    Micro-90…The Lab Tech’s Best Friend

    Many labs rely on Micro-90 for manual and ultrasonic cleaning of glassware and equipment. Micro-90 is a mild, yet powerful, multipurpose, alkaline cleaning concentrate that is excellent for removing a vast array of soils from flasks, pipettes, slides, stainless steel, plastic, glass, and other laboratory equipment and surfaces. Micro-90 contains ionic and non-ionic ingredients which combine to produce a variety of cleaning actions. Micro-90 lifts, disperses, emulsifies, sequesters, suspends, and decomposes soils, then rinses away leaving the surface absolutely clean. When properly rinsed, Micro-90 does not leave any residue.

    Why Lab Tech’s Love Micro-90:

    • Effective on a wide range of soils

    • Compatible with most hard surfaces
    • Manufactured in a dedicated system
    • Filtered to 1 Micron
    • Can be used for manual, CIP, and ultrasonic cleaning applications
    • Free rinsing, does not leave residue or product build-up
    • Cleaning validation methods are available
    • Safe, environmentally friendly formula
    • Economical, concentrated formula that is easy to dilute
    • NSF registered as USDA-A1 Cleaner
    Still not convinced? Request a free sample for testing and try Micro-90 for your most challenging lab cleaning applications!
  6. Best of 2018: IPC’s Top 5 Posts of the Year

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    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.

    Our employees banded together during the holiday season making donations to local causes to help those in need.

    Our popular blog continues to attract new followers and provide our customer base with informative and helpful product and industry insights.

    As the year comes to an end, we want to thank all of our loyal followers and customers for helping to make 2018 a great year.

    Below are our 5 most popular blog posts of 2018:

    1. 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?…

    2. Everything You Need To Know For Easy O-ring Installation

    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…

    3. Save Time And Money With 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!…

    4. 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!…

    5. 10 Things To Know When Choosing An Assembly 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….

    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!

  7. Ergonomics: A Winning Formula For Improved Quality, Safety And Production

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    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.

    our 20-liter liquid filling line

    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 Output
    • 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!

     

  8. Reclaiming Water To Maintain Future Economic Growth

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    The Challenge

    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 History

    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.

    The Problem

    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.

    The Test

    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.

    The Solution

    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.

    The Product

    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.

    Read more about cleaning filter membranes here:
    How To Choose the Proper Membrane Cleaner
    Make Your Membranes Last…A Simple 10 Step Guide
  9. The ABC’s of Cleaning Validation: A Simple Primer

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    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
    • Acceptance criteria
    • When revalidation is required
    • Sampling procedures
    • 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

    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.

    Download IPC’s validation overview or contact our technical specialists for detailed validation methods.

  10. Guidelines For Cleaning Pharmaceutical Processing Equipment

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    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.
    • Provide a clean surface for disinfection. Surfaces cannot be properly sanitized or disinfected if they are not thoroughly cleaned first.
    • 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

    Federal Regulations

    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.

    Cleaning Procedures

    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.
    • Type of water – deionized, distilled or tap
    • Number of rinse steps required
    • Drying and storage guidelines
    • Instructions for visual inspection after cleaning
    • Cleaning validation methods

    How to Clean

    Several factors must be taken into consideration to set up an effective cleaning process and remain in compliance with federal regulations.

     Soils

    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.

    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 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.

    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 contaminants.

    Cleaning Validation

    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.

    Download IPC’s “7 Step Guide to the Proper Usage of Critical Cleaners” for more information on establishing a cleaning regimen.

    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.

Detergent Selection Guide

= Used ; = Preferred
SOILS Micro-90® Micro® Green Clean Micro® A07 Surface-Cleanse/930® LF2100® Zymit® Low-Foam Zymit® Pro
Adhesives
Biofilm
Biological soils: Blood, Feces, Mucous, Sebum, Sweat, Urine
Dyes, Inks
Eggs, Butter, Fruit Stains
Emulsifiers
Fat
Fingerprints
Flavor, Fragrances
Gelatin
Gels
Grass
Insoluble Salts
Milkstone
Oils
Oxides
Paraffins
Petrolatum
Proteins
Scale
Shop Dusts, Soldering Flux
Silicons
Starch
Tar
Tissue
Titanium Dioxides