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Tag Archive: cleaning before disinfecting

  1. 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.

  2. 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.

  3. How to Properly Clean Medical Devices

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    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.

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

    Cleaning and Sterilizing

     What’s the Difference?

    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.

  4. Cleaning and Disinfecting…Why You Need To Do Both

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    Cleaning and Disinfecting Are Not The Same

    Cleaning and disinfecting achieve two distinctly different objectives. Each plays an extremely important role in getting equipment ready to be used for food processing or pharmaceutical manufacturing. It is important to understand the differences between the two, and how each contributes to the overall preparation of manufacturing equipment.

    What is Cleaning?

    Cleaning refers to removing all dirts and soils from a surface. Detergents are used to clean surfaces. “Cleaning is the complete removal of…soil using appropriate detergent chemicals under recommended conditions.” (IFAS 2015 http://www.edis.ifas.ufl.edu/fs077).

    What is Disinfecting?

    Disinfecting refers to destroying or killing any germs, microbes or bacteria that are present on the surface. Disinfectants are used to accomplish this task. “A disinfectant is a product which kills microbes without employing a soil removal action”. (Safefood 360 2012 http://safefood360.com/resources/Cleaning.pdf).

    Why do both?

    It is imperative to thoroughly clean surfaces 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.

    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 possibly 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.

    Cleaning procedures for surfaces in food processing and pharmaceutical manufacturing facilities should include the following steps:

    1. Removal of large debris
    2. Surface rinse
    3. Cleaning with a specialty detergent
    4. Post cleaning rinse
    5. Disinfection
    6. Rinse
    7. Validation

    By thoroughly cleaning surfaces prior to disinfection, manufacturers can feel confident that they have taken the necessary steps to provide a clean and germ-free environment. Validating the cleaning and disinfecting procedures corroborates those steps.

    Interested in learning more about specialty cleaners for use in food & beverage or pharmaceutical manufacturing facilities? Need assistance in choosing the right product for your critical cleaning application? Visit International Products Corporation’s website or contact one of our technical specialists.

    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