Comments Off on The Importance of Cleaning Before Disinfecting
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.
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.
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?
Comments Off on A Look Back: IPC’s Top 5 Blog Posts of 2019
2020 marks the start of a new year and a new decade. The start of a new year also provides an opportunity to reflect on what was learned over the past year. At IPC, we’re thrilled to see how the popularity of our blog has grown exponentially over the past year. Some of you liked the blog posts so much, you came back more than once! Here is a review of our most popular posts of 2019.
IPC’s 5 Most Popular Posts of 2019
1. 5 Reasons Why P-80 Is the Best O-Ring Lubricant
Remember the last time you had to install an O-ring? Maybe you were assembling new equipment or repairing a pump. Regardless of the type of equipment involved, unless you used an O-ring lubricant chances are you may have struggled with the installation….
2. Why Micro-90® is A Lab Tech’s Best Friend
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….
3. Do You Need P-80® Temporary Rubber Assembly Lubricants?
How many times have you pushed a rubber hose onto a fitting only to find it wouldn’t slide into place because the fit was just too tight? Or, how about all of those seals and O-rings that twisted or tore because it took so much force to seat them? Remember the frustration you felt after pushing a grommet into place and then watching it pop right back out?…
4. 5 Step Guide to Choosing The Right Assembly Lubricant
Rubber can be difficult to install, remove or manipulate. It’s not unusual for rubber parts to slip or break during assembly or not fit into place: an O-ring may get twisted, a heater hose may not fully insert, or a gap can appear in a waterproof seal. Improper assembly can lead to a multitude of problems including destroyed parts, invalidated warranty claims, product recalls, and worker fatigue or injury…
5. Selecting the Right Ultrasonic Cleaning Detergent for Regulated Industries
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.
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.
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!
Comments Off on What Is The Shelf Life Of My Cleaner? (And, Why It Matters)
Remember that bottle of cleaner that’s been in your cabinet for years? How do you know if it’s still effective and safe to use? These things are good forever, right?
Absolutely not! Chemical products do indeed have a shelf life. Paying attention to expiration dates helps ensure you are using products at their peak performance levels for optimal results.
What Is Shelf Life?
The shelf life of a product is defined as the “length of time that a commodity may be stored without becoming unfit for use, consumption, or sale.” (https://en.m.wikipedia.org/wiki/Shelf_life). It’s important to note that manufacturers determine the shelf life of a product based upon expectations of normal use and storage. Failure to follow recommended guidelines can limit the expected shelf life of any product.
How Is Shelf Life Determined?
While each product and each manufacturer is unique, shelf life is generally determined by assessing product stability under normal conditions over an extended period of time. Are the active ingredients still effective or have they deteriorated? Chemical composition and anticipated environmental factors both have a role in determining a product’s shelf life.
Product quality can be assessed by determining the concentration of key ingredients. Once the active ingredients of a product begin to degrade, product strength may be diminished.
Environmental factors include temperature, moisture and exposure to air. External contaminants or stresses can also affect product quality.
All of IPC’s products are stamped with a six-digit lot number that signifies the date of manufacture (YY/MM/DD). For example, a lot number of 190301 signifies that the product was manufactured on March 1, 2019. The product expiration date is stamped directly below the lot number.
How Does IPC Calculate Shelf Life?
The shelf life of IPC’s products is determined by observation and testing. Part of the manufacturing process includes retaining a sample of each lot number produced for quality control.
To determine the shelf life of its cleaners, IPC tests for changes in pH, specific gravity and detergency.
What Other Factors Affect Shelf Life?
The manner in which products are handled by the end user may also influence shelf life. It’s always a good idea to follow the manufacturer’s recommendations for use, storage and handling. Follow these steps to maintain product quality and get the most out of your cleaner:
Store at recommended temperatures
Properly close containers between use – do not leave bottles uncapped
Do not mix with other chemicals
Use clean tools to avoid introducing contaminants
Follow manufacturer’s instructions for use
What Happens If I Use My Cleaner After The Expiration Date?
Using products beyond their expected expiration date is not recommended. The detergency of your cleaner may have diminished, which can have an impact on your cleaning application. If you have questions about whether or not it’s okay to use your product, contact the manufacturer for assistance.
Comments Off on Why Micro-90® is A Lab Tech’s Best Friend
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:
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 afree sample for testing and try Micro-90 for your most challenging lab cleaning applications!
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 Guidelines For Cleaning Pharmaceutical Processing Equipment
Cleaning pharmaceutical processing equipment is challenging. Cleaning methods, soils present, type of manufacturing equipment, surfaces cleaned, choice of cleaning detergent and temperature should all be considered when setting up a cleaning procedure. Cleaning validation methods are required. The entire cleaning process must be standardized and documented according to the FDA’s cGMP regulations.
Why Clean Pharmaceutical Processing Equipment?
Maintain product quality.
Remove all trace ingredients to prevent the transfer of ingredients from one product to the next. This is especially important when multiple products are produced on the same equipment.
Prevent equipment malfunctions that may lead to product contamination.
Comply with local and international standards and regulations to ensure consumer safety and avoid legal issues.
Increase plant performance and productivity by diminishing waste, maintaining equipment and preserving product quality.
Enhance worker safety by providing a clean working environment and smoothly functioning equipment.
Establishing A Cleaning Procedure
Pharmaceutical manufacturers are required to set up a fully documented written cleaning procedure for each piece of processing equipment in compliance with FDA 21 CFR Part 211.67. Documentation should include:
Responsibility for equipment cleaning and maintenance
Cleaning and sanitization schedules
A detailed description of the cleaning procedure
Removal of previous batch identification
Protection of clean equipment
Inspection of equipment prior to use
Manufacturers must outline each of these steps in detail to be sure that all processes are followed clearly and succinctly.
Federal regulations require a very specific description of each step of the cleaning procedure. The following details should be documented.
Frequency of cleaning – including time requirements between processing products and cleaning
Cleaning tools used – any sponges, brushes, scrapers, sprayers, wipes or equipment used to aid the cleaning process
Establishment and sequence of each cleaning step
Identification of each specific piece of equipment to be cleaned, including instructions for cleaning between batches of the same or different products
Cleaning method – clean-in-place (CIP) or clean-out-of-place (COP)
Detailed instructions for any required disassembly and re-assembly of equipment if COP methods are used. Instructions should specify the parts to be removed and any assembly aids used during this process.
Identification of all cleaning detergents and detailed instructions for their use. Usage instructions should include amounts, concentration, temperature, dwell time and application method.
Soils found on pharmaceutical processing equipment may be traces of the various ingredients used in production or soils from the actual manufacturing process such as oil, grease, dust or minerals. Understanding the soils that are present will guide your choice of cleaning detergent.
Gels, polyethylene glycol, oils, titanium dioxide, dyes, silicons, flavorings, petrolatum, paraffin, proteins, steroids, sugars, alcohol, stearates, and cornstarch are some of the typical foulants that are often found on pharmaceutical processing equipment.
Each type of soil is unique and requires the proper detergent to thoroughly clean the surface. Choose a cleaner that will best attack the soils you are trying to remove. Alkaline cleaners are the best choice for cleaning soils such as gels, dyes and petrolatum, while citric acid based cleaners are better suited for removing titanium dioxide. Protein or starch-based soils may require the use of an enzyme cleaner. Use the table below to help match the most effective type of cleaner to each kind of soil.
Type of Equipment
Mixing tanks, tablet presses, capsule fillers, centrifuges, granulators, filling lines, mixers, conveyors, filters, fluid lines, batch process tanks, tubes and flasks all need to be thoroughly cleaned. The design of the equipment must be taken into consideration. By nature of its construction, some types of equipment will be more difficult to clean than others. Hidden parts and blind holes present unique challenges.
Another important factor to consider is the how the equipment is used. Are you cleaning a dedicated production system or equipment that is used to produce a range of products? Processing equipment used to produce multiple products has a greater chance of cross contamination of ingredients.
It’s also important to select a cleaner that is compatible with the surface of the equipment you are cleaning. The cleaner manufacturer should be able to guide you and provide compatibility studies for their products.
Cleaning Method and Location
Clean-in-place (CIP) or Clean-out-of-place (COP)?
CIP is generally used for large systems and components that cannot easily be taken apart. CIP often results in less downtime since it eliminates the need to take apart or move the equipment. Automated systems, spray systems and immersion are all examples of CIP operations.
COP is most often used for smaller pieces of equipment or smaller parts of larger equipment that can be removed and re-assembled after cleaning. COP can involve either manual washing or use of machine washers. Specific instructions for disassembling and re-assembling equipment must be followed.
What cleaning method will you use?
Manual, ultrasonic, spray, machine and automated systems are all used for cleaning pharmaceutical equipment. The type of cleaning method used will impact your choice of detergent. Automatic parts cleaners and high-pressure washers require low foaming detergents.
In most cases, increasing the temperature is one of the best ways to speed up or improve the cleaning action. The temperature parameters that should be used for any individual cleaning application will depend upon the equipment and the soils that are present, as well as your choice of detergent and wash method. Check with the manufacturer for the maximum suggested operating temperature for your detergent.
The length of the cleaning cycle contributes to the effectiveness of your cleaning application. In most cases, a longer dwell time will improve the results. However, all factors – soils, temperature, substrate, detergent and cleaning method must be taken into consideration.
Thorough rinsing should follow cleaning. Rinsing removes any excess detergent left on the item. For critical cleaning applications, it is best to use deionized or distilled water, as rinsing with ordinary water may introduce new contaminants.
Cleaning validation is a part of the regulatory compliance process for cleaning pharmaceutical processing equipment. Validation ensures that all equipment is washed according to previously determined standards and that all traces of soil and detergent are removed. Validation methods are unique to each detergent and should be available from most cleaner manufacturers.
Need help choosing the right specialty cleaner for your pharmaceutical cleaning application? Contact one of International Products Corporation’s (IPC) technical specialists or request a free cleaner sample for testing. All of IPC’s specialty cleaners are registered with NSF as A1 cleaners and can be validated in FDA processes.
Comments Off on An Easy Guide to Understanding Surfactants
What is a Surfactant?
Surfactants are a primary component of cleaning detergents. The word surfactant means surface active agent. As the name implies, surfactants stir up activity on the surface you are cleaning to help trap dirt and remove it from the surface.
Surfactants have a hydrophobic (water-hating) tail and a hydrophilic (water-loving) head. The hydrophobic tail of each surfactant surrounds soils. The hydrophilic head is surrounded by water.
How do surfactants work?
When there are a sufficient amount of surfactant molecules present in a solution they combine together to form structures called micelles. As the micelle forms, the surfactant heads position themselves so they are exposed to water, while the tails are grouped together in the center of the structure protected from water.
The micelles work as a unit to remove soils. The hydrophobic tails are attracted to soils and surround them, while the hydrophilic heads pull the surrounded soils off the surface and into the cleaning solution. Then the micelles reform with the tails suspending the soil in the center of the structure.
Types of Surfactants
The hydrophilic head of each surfactant is electrically charged. The charge can be negative, positive, or neutral. Depending on the charge of the hydrophilic head, the surfactant is classified as anionic, nonionic, cationic or amphoteric.
Anionic surfactants have a negative charge on their hydrophilic end. The negative charge helps the surfactant molecules lift and suspend soils in micelles. Because they are able to attack a broad range of soils, anionic surfactants are used frequently in soaps and detergents. Anionic surfactants create a lot of foam when mixed. While anionic surfactants are excellent for lifting and suspending particulate soils, they are not as good at emulsifying oily soils.
Sulfates, sulfonates, and gluconates are examples of anionic surfactants.
Nonionic surfactants are neutral, they do not have any charge on their hydrophilic end. Nonionic surfactants are very good at emulsifying oils and are better than anionic surfactants at removing organic soils. The two are frequently used together to create dual-action, multi-purpose cleaners that can not only lift and suspend particulate soils, but also emulsify oily soils.
Certain nonionic surfactants can be non-foaming or low-foaming. This makes them a good choice as an ingredient in low-foaming detergents.
Nonionic surfactants have a unique property called a cloud point. The cloud point is the temperature at which the nonionic surfactant begins to separate from the cleaning solution, called phase separation. When this occurs, the cleaning solution becomes cloudy. This is considered the temperature for optimal detergency. For low foaming cleaners, optimal detergency is at the cloud point; for foaming cleaners optimal detergency is either just below the cloud point or at the start of the cloud point. The agitation of low foaming cleaners is sufficient to prevent phase separation.
The temperature of the cloud point depends upon the ratio of the hydrophobic and hydrophilic portions of the nonionic surfactant. Some cloud points are at room temperature while others are very high. Some nonionics don’t have a cloud point because they have a very high ratio of hydrophilic to hydrophobic moieties.
Examples of some common nonionic surfactants include ethoxylates, alkoxylates, and cocamides.
Cationic surfactants have a positive charge on their hydrophilic end. The positive charge makes them useful in anti-static products, like fabric softeners. Cationic surfactants can also serve as antimicrobial agents, so they are often used in disinfectants.
Cationic surfactants cannot be used with anionic surfactants. If positively charged cationic surfactants are mixed with negatively charged anionic surfactants, they will fall out of solution and no longer be effective. Cationic and nonionic surfactants, however, are compatible.
Examples of some common cationic surfactants include alkyl ammonium chlorides.
Amphoteric surfactants have a dual charge on their hydrophilic end, both positive and negative. The dual charges cancel each other out creating a net charge of zero, referred to as zwitterionic. The pH of any given solution will determine how the amphoteric surfactants react. In acidic solutions, the amphoteric surfactants become positively charged and behave similarly to cationic surfactants. In alkaline solutions, they develop a negative charge, similar to anionic surfactants.
Amphoteric surfactants are often used in personal care products such as shampoos and cosmetics. Examples of some frequently used amphoteric surfactants are betaines and amino oxides.
How Surfactants are used in Cleaners
Surfactants are a key ingredient in cleaning products. One thing that differentiates cleaning products is how they are made. Cleaners made from a single chemical, targeting a specific type of soil, are referred to as commodity cleaners. Cleaners that are blends of various chemical ingredients designed to work together to remove various types of soils are referred to as formulated cleaners.
Formulated cleaners usually contain four basic elements: surfactants, hydrotropes, builders and carriers. Hydrotropes are chemicals that keep the otherwise incompatible surfactants and builders stable in a solution. The carrier is either water or a solvent. These elements work together to create mechanical actions to remove soils. The end result is a product that can attack dirt on surfaces with a variety of cleaning mechanisms including emulsifying, lifting, dispersing, sequestering, suspending and decomposing soils of various types. The type of surfactants used in a cleaning product largely determines which soils they will be best at removing.
IPC offers a full line of formulated cleaners that among the safest yet most effective solutions on the market. Request a free sample to test our products for your most challenging cleaning applications.
Comments Off on How to Properly Clean Medical Devices
When it comes to medical devices cleanliness is crucial. All medical devices, whether they are disposable, implantable or reusable, must be cleaned during the manufacturing process to remove oil, grease, fingerprints and other manufacturing soils. Reusable products must also be thoroughly cleaned and sterilized between each use to avoid infecting patients or causing illness. Reaching the right level of cleanliness does not come automatically. A well planned cleaning regimen must be developed and followed carefully.
Developing a Cleaning Process
Medical device manufacturers must provide proof that their products can be adequately cleaned as part of the FDA approval process. As a result, most manufacturers now incorporate setting up a cleaning protocol as part of the design and development phase.
Factors to consider when setting up a cleaning regimen:
Soils: Choose a cleaner that will best attack the soils you are trying to remove. Enzyme cleaners are often used for medical device cleaning applications since they work well at removing organic soils. Protease enzymes in particular are a good choice for protein based organic soils like blood, fat, sweat, mucous, feces and tissue.
Surface: Titanium, plastic, ceramic, silicone and metal are some of the more common materials used in the manufacture of medical devices. It’s important to select a cleaner that is compatible with the substrate of the device you are cleaning. The cleaner manufacturer should be able to guide you and provide compatibility studies for their products.
Wash method: Common methods of cleaning medical devices include automatic washers, ultrasonic cleaners and manual washing. Factors such as soil, substrate, composition and end use of the device are taken into consideration. Regardless of the method used, it’s extremely important to be sure that all soils are removed from blind holes and internal passages of the device.
Temperature: In most cases, increasing the temperature is one of the best ways to speed up or improve the cleaning action. The temperature parameters that should be used for any individual cleaning application will depend upon the make-up of the medical device and the soils that are present, as well as your choice of detergent and wash method. Check with the manufacturer for the maximum suggested operating temperature for your detergent.
Dwell time: The length of the cleaning cycle contributes to the effectiveness of your cleaning application. In most cases, a longer dwell time will improve the results. However, all factors – soils, temperature, substrate, detergent and cleaning method must be taken into consideration.
Rinse step: Thorough rinsing should follow cleaning. Rinsing removes any excess detergent left on the item. For critical cleaning applications it is best to use deionized or distilled water, as rinsing with ordinary water may introduce new contaminates.
Validation procedures: Cleaning validation is a part of the regulatory compliance process for medical device manufacturing and reprocessing. Validation ensures that medical devices are washed according to previously determined standards and that all traces of soil and detergent are removed. Validation methods are unique to each detergent and should be available from most cleaner manufacturers.
Medical devices not only need to be clean, they also need to be sterile. Medical devices that are not properly cleaned and sterilized can lead to patient infection. Cleaning and sterilization are two distinct processes and both must be performed to ensure that medical devices meet safety standards.
The CDC defines cleaning as “the removal of foreign material (e.g., soil, and organic material) from objects…normally accomplished using water with detergents or enzymatic products”. (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html). They describe sterilization as a process that “destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item”. (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/index.html). The CDC has established guidelines that are used to determine if a medical device is considered sterile. This is referred to as the sterility assurance level or SAL of a product and is defined as the likelihood that any viable microorganisms will exist on a device after sterilizing.
Why do Both?
Clearly we have two different, albeit related, processes. So, why do both? Cleaning the medical devices first ensures that they are free from soils and debris that can cause infection and reduce the efficiency of the sterilization process.
The CDC guidelines explain that “Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective.” (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html).
If a surface is sterilized or disinfected before it is cleaned, the remaining soils can still contribute to the growth of harmful germs and lead to further contamination. Lingering soils on the surface of the medical device can serve as a barrier and impact the efficiency of the sterilization process. If the surface is thoroughly cleaned first, and validated for cleanliness, sterilization is much more effective.
Interested in learning more about choosing the right specialty cleaner for your medical device cleaning application? Contact one of International Products Corporation’s (IPC) technical specialists or request a free cleaner sample for testing. All of IPC’s specialty cleaners are registered with NSF as A1 cleaners and can be validated in FDA processes.