Are cleanrooms a critical part of your business? If so, you know that they can be finicky at times. You have to maintain exact standards, and when your cleanroom is down, so is your company.
So, what can you do to ensure that your cleanroom always functions according to its required standards?
Though it might sound obvious, keeping it well stocked with necessary cleanroom supplies is the best way to keep your cleanroom performing to standard.
5 Important Cleanroom Supplies You Should Always Have
Below is a list of five essential cleanroom supplies you should always have on hand and what makes them so important.
1. Replacement Filters
Filters are what keep the air in a cleanroom clean. Without filters, your cleanroom has little hope of performing to standard. So, it’s good to always have backup filters on hand, both HEPA, ULPA, and pre-filters. But how many should you have?
Pre-filters: Depending on the standards your cleanroom has to meet, you probably change your pre-filters once every few months. Every time you change them, you should ensure you have enough replacements to last at least one more change. Otherwise, you risk putting your operation behind.
HEPA/ULPA: For HEPA or ULPA filters, it’s a good idea to keep one or two replacements on hand in case a situation arises where a filter needs to be changed unexpectedly. Having replacements ready ensures you’re prepared for any emergency.
2. Gowning Materials
If you regularly order cleanroom supplies, you know that you go through boxes of gowning materials in no time. Hoods, bunny suits, booties, and cleanroom gloves are crucial to your everyday operations. It’s important that your company develop some sort of system so that you never run out of these essential cleanroom supplies.
For example, have employees alert the person in charge of ordering cleanroom supplies whenever you have less than two weeks’ worth of a certain gowning material. Whether it’s gloves or cleanroom suits, a good rule of thumb is that when you open the last box of cleanroom supplies, you order another shipment.
3. Cleanroom Cleaners
While this might sound like common sense, it’s surprising how quickly you can run out of cleanroom cleaning supplies. Maybe you’ve experienced that feeling of dread when an employee reports and says that there aren’t any more bottles of cleaner. There’s nothing worse than frantically trying to find the right cleaner and then making sure it gets shipped overnight so your cleanroom can continue functioning at standard for the next business day.
Similar to gowning materials, it’s a good idea to have a system in place to prevent this sort of situation. Make sure you always have at least one full bottle of disinfectant or cleaner.
4. Cleanroom Wipes
Cleanroom wipes are specifically designed to clean surfaces within the cleanroom without introducing additional contaminants. They’re often made from lint-free materials and are pre-saturated with a cleaning solution safe for use in controlled environments. They’re used to wipe down surfaces, equipment, and even personnel as needed to maintain cleanliness. Their ability to clean without leaving residue makes them indispensable for maintaining the strict hygiene standards required in cleanrooms.
It’s best to monitor your usage and set up automatic reorders based on your average consumption rate. We also suggest storing an emergency supply of wipes to prevent unexpected running out.
5. Sticky Mats
Sticky mats are your first line of defense against contamination. They’re placed at the entrance to trap dirt, dust, and other contaminants from shoes or equipment wheels before they enter the controlled environment. Regularly replacing sticky mats is crucial, as they significantly reduce the risk of particles entering your cleanroom, which can otherwise lead to costly downtime and compromised products.
We recommend keeping an inventory log of your sticky mats and setting a schedule for regular replacements. Consider ordering in bulk to ensure you always have an ample supply.
Trust Angstrom for Expert Cleanroom Design and Supplies
If you need cleanroom supplies or are considering the design of a new facility, trust the experts at Angstrom. We specialize in designing cleanrooms that meet your exact specifications and standards and offer a full range of replacement cleanroom supplies to keep your operations running smoothly.
Visit our website or call us at 888-768-6900 for all your cleanroom needs!
After investing in a top-of-the-line cleanroom, keeping it in pristine condition is crucial, especially when adhering to cGMP compliance.
When properly cared for, a cGMP cleanroom will function at peak performance, ensuring that all processes meet strict regulatory standards. However, failure to adhere to cGMP cleaning standards can lead to contamination, jeopardizing product quality and resulting in costly regulatory issues that can disrupt daily operations.
Here’s a rundown of the best cleaning cleanroom procedures and practices for your cGMP-compliant cleanroom.
What Are cGMP Requirements for Cleanroom Cleaning?
cGMP, or Current Good Manufacturing Practices, are regulations enforced by the FDA to ensure that products are consistently produced and controlled according to quality standards. These regulations are particularly crucial in pharmaceuticals, biotechnology, and medical device manufacturing, where product safety and efficacy are paramount.
Classifications of cGMP Cleanrooms
cGMP cleanrooms are classified based on their ISO standards, which define the cleanliness level required for different types of manufacturing environments. The most common classifications include:
ISO 5 (Class 100): These cleanrooms have the strictest cleanliness requirements, allowing only 3,520 particles (0.5 microns or larger) per cubic foot of air. They are often used in critical processes such as aseptic filling and sterile drug manufacturing.
ISO 6 (Class 1,000): Allows for 35,200 particles per cubic foot and is typically used in processes like vial filling or assembly of sterile devices.
ISO 7 (Class 10,000): Permits 352,000 particles per cubic foot and is commonly found in less critical manufacturing processes, such as packaging or certain laboratory environments.
The classification of your cleanroom dictates the stringency of the cleaning protocols. For example, an ISO 5 cleanroom requires more frequent and thorough cleaning than an ISO 7 cleanroom due to the higher sensitivity to particulate contamination.
6 Effective Cleanroom Cleaning Strategies For cGMP Requirements
1. Follow Industry-Specific Standards
Cleanrooms vary widely in use, and cGMP cleanrooms have unique requirements and standards they must adhere to depending on the industry. For example, cGMP cleanrooms in pharmaceuticals must adhere to extremely stringent standards to prevent contamination that could compromise the safety and efficacy of drugs.
Depending on your industry, your cGMP cleanroom will have a specific layout, ISO rating, and cleanliness standard. Therefore, its cleaning schedule and procedure will also differ.
Cleanrooms with higher ISO ratings, like ISO 5, for example, must be kept at much higher sanitation levels to reduce the chance of interference from minute particles and contaminants.
Cleanrooms with lower class ratings, such as ISO 7, may be less threatened by certain contaminants or smaller particle sizes, but they still require regular cleaning to maintain standards and efficiency.
2. Follow Contamination Prevention Protocols
In a perfect world, zero contaminants would enter your cleanroom environment. While this is virtually impossible, the best way to keep your cGMP cleanroom clean is to follow strict contamination prevention protocols designed to meet cGMP requirements. These protocols include:
Proper Gowning Procedures: All personnel must adhere to cGMP-specific gowning protocols. This includes wearing sterile, non-powdered gloves, sterile gowns, masks, and other protective gear.
Sterilization and Equipment Usage: All tools and equipment used in a cGMP cleanroom must be sterilized according to cGMP standards, including ensuring that all cleaning tools, garments, and materials are appropriately sanitized before use to prevent contamination.
Strict Entry Procedures: Entry protocols may involve multiple stages of decontamination, such as air showers, sticky mats, and separate gowning areas, ensuring that personnel and materials are free of contaminants before entering.
Importance of Training Staff in cGMP Practices: To minimize risks, staff members should be trained in cGMP contamination prevention practices.
Keeping your workspace clean requires diligent adherence to daily and weekly cleaning schedules. Depending on the strictness of your class standard, you may need to add more rigorous objectives or increase the frequency of these tasks.
Whatever your facility requires, it’s essential to create and follow a cleaning schedule that clearly defines all assignments, making them easy to understand and follow. Here are the general cleaning protocols recommended for broad cleanroom needs:
Daily Cleanroom Cleaning:
Before a shift begins, use a damp mop on floors and vacuum to dry.
Vacuum all walls using a HEPA filter vacuum.
Wash and wipe all windows and pass-throughs dry.
Wipe down all work areas at the end of every shift. This should occur more frequently in cleanrooms with higher standards.
Put away products and supplies between shifts to prevent further contamination.
Weekly Cleanroom Cleaning:
Mop floors with a cleanroom-specific detergent, distilled water, and a HEPA filter vacuum.
Wipe walls with a damp sponge and distilled water, then vacuum dry.
As Needed:
Remove any residue or deposits on ceilings by washing with detergent and distilled water.
Using a damp sponge, wipe off all light lenses.
Change sticky mats as soon as you notice wear.
Note: This FDA document provides an extensive, detailed look at cGMP standards and regulations.
4. Use cGMP-Approved Products Approved for Cleaning Cleanrooms
Cleaning products that are improperly sterilized or unsuitable for cleanroom use can cause contamination, particularly in cGMP cleanrooms where maintaining strict standards is critical.
Using only cleaning products that are cGMP-approved, non-reactive, and specifically designed for cleanroom environments is essential. This includes using deionized and distilled water for mopping and wiping surfaces and cleanroom-specified cleaning agents that meet cGMP standards. All chemicals and solvents for cleaning must be neutral, non-ionic, and non-foaming to avoid buildup on surfaces over time, which could compromise the cleanliness of the environment.
Cleanroom Cleaning Tips:
High ISO class cleanrooms (ISO levels 5-7) often require sterilizing disinfectants before use, further protecting the cleanroom from contaminants.
Never use scrubs or rags that could shed or corrode surfaces. Instead, only use woven polyester specified for cleanroom use.
Follow a mopping protocol that efficiently cleans floors without spreading dirty water over cleaned areas. Employ a mopping system that separates dirty and clean water and won’t scratch or contaminate the floor or walls.
Bringing all needed materials—such as brooms, mops, and cleaning agents—into the cleanroom before cleaning is good practice. This way, once the process is complete, you only need to exit once, reducing the possibility of contamination.
Note: For a detailed list of cGMP-approved products for cleaning cleanrooms, visit the FDA website here.
5. Properly Train Staff on cGMP Cleaning Procedures & Maintenance
All staff members and janitorial personnel must be rigorously trained in cGMP cleaning protocols to ensure compliance and maintain the cleanroom’s class standards. This includes comprehensive education on gowning procedures, environmental sterilization practices, general equipment maintenance, and more.
Staff should be equipped to handle spills or other incidents that could lead to contamination. Tools and cleaning supplies should be easily accessible but not stored in a way that could lead to cross-contamination. To support this, having guides and cleaning checklists posted visibly in the room can help staff consistently follow cGMP protocols and maintain a sanitary environment
6. Conduct Regular Inspections and Monitoring for cGMP Compliance
Even if you’re doing everything right and following the proper cleanroom procedures, it’s crucial to conduct regular inspections and environmental monitoring to ensure ongoing cGMP compliance. Regular checkups help verify that your cleanroom consistently meets cGMP standards, preventing potential lapses that could lead to contamination or non-compliance.
Cleanroom Inspection & Monitoring Tips:
Air samplers or settle plates can be used to test for organisms and measure particles per cubic foot, ensuring that the cleanroom environment remains within the required cleanliness levels.
Regular checkups of your HVAC system play a vital role in maintaining cGMP compliance. The HVAC system controls temperature, humidity, and air filtration, all of which are critical factors in ensuring the cleanroom environment remains stable and free from contaminants. A properly functioning HVAC system will maintain a steady temperature and humidity level, consistently changing air to meet your ISO specifications, which is essential for preserving the cleanliness and integrity of the cleanroom.
Utilize cleanroom experts to inspect, monitor, and repair your cleanroom. At Angstrom, our tailored maintenance and repair services ensure your cleanroom continues to meet the highest industry standards. When the unexpected occurs, our team is ready to assist wherever needed.
Count On Expert Cleanroom Maintenance Solutions From Angstrom Technology
If you’re cleaning your cleanroom and still not getting the desired results, it might be time for specialized maintenance. To ensure your cleanroom remains compliant with cGMP standards, it’s crucial to consult with experts like our expert team at Angstrom.
Whether you need help troubleshooting specific issues or want to enhance your cleaning protocols, our expertise can ensure your cleanroom always functions to the best of its ability. Contact us today to learn more!
In many medical cleanroom applications, the slightest risk of contamination could have disastrous consequences for the development or testing of products. For this reason, garments are used to protect employees and processes. The purpose of the cleanroom gowning procedure is to limit particles that get in or on garments before entering the cleanroom. Once you have a cleanroom gowning procedure laid organized, make sure it is clearly communicated to all employees and posted in a visible location within the gowning room itself.
Having a procedure for donning protective equipment is crucial for the safety of your operations, although the gowning process itself as well as the cleanroom supplies and garments used will vary depending on your cleanroom’s application and the classification requirements for your cleanroom. Let’s walk through an example of a cleanroom gowning procedure that can be used for many medical cleanrooms.
Medical Cleanroom Gowning Procedure
A comprehensive cleanroom gowning procedure involves three stages, which are translated into distinct areas within the gowning room. Each must be kept separate in order to limit contamination. The three areas used in the cleanroom gowning procedure are:
The Pre-Changing zone: for the removal of items not worn under garments
The Changing zone: for donning and storing garments and cleanroom supplies
The Entrance zone: to conduct final checks before entering the cleanroom
Before beginning the cleanroom gowning procedure, employees must have recently showered, be wearing clean clothing and hair covers, and be as personally clean as possible.
Pre-Change Zone
The pre-change zone is the preliminary step of the cleanroom gowning procedure, where the majority of particles are removed prior to entering the cleanroom. In this zone, a sticky mat is used to clean the soles of the employee’s shoes. The employee must also remove clothing that won’t be worn in the cleanroom under the garment and store items safely where they can’t shed particles or contaminate clean garments.
In the pre-change zone, there will be a place for employees to scrub hands for a minimum of thirty seconds. Afterwards, they can apply a disinfectant and sterile moisturizer before moving onto the changing zone.
Changing Zone
Employees enter the changing zone by passing over a bench or into a separate room. In this area, they will don gloves, put on a facemask, select garments, and put on any necessary headgear and garments without touching the floor or other items in the room. While changing, the employee should take care to touch as little of the garments as possible. Specific gloves can be worn for this process if necessary to ensure no particles are carried onto the garments themselves.
With the proper attire donned, the employee will tuck their sleeves into their gloves and put on boots or shoe covers carefully so that they don’t touch the “dirty” area where they previously tread.
Entrance Zone
The entrance zone is the final area of the gowning room, and the final stage of the cleanroom gowning procedure. It will have a full-length mirror and a place where employees can wash their hands to disinfect them one more time before entering the cleanroom.
In the mirror, the employee should do a thorough visual check that the garment is worn properly and tucked in the necessary places — around sleeves and gloves, into boots, etc. — and that any headgear is secured and clean. The gloves should also be checked, and replaced if torn or contaminated before reaching the entrance zone. Once the check is complete, the employee may enter the cleanroom.
The cleanroom gowning procedure may seem extensive or complicated, but it is vital to limit the potential level of contamination entering the cleanroom. However, implementing a solid procedure is only part of this task. The cleanroom gowning procedure depends on a thoughtfully designed gowning room in order to be effective.
Medical Cleanroom Design: Gowning Rooms
The medical cleanroom design should facilitate a proper gowning procedure by including the necessary space for gowning rooms and the three zones within them, including the pre-changing zone, the changing zone, and the entrance zone. Each area should be equipped with the furniture and cleanroom supplies employees will need as they move through the cleanroom gowning procedure. These supplies include benches and cabinets for changing areas and storage of both clean garments and dirty ones — which must be kept in separate and secure areas.
The structure of the gowning room must also facilitate the cleanroom gowning procedure. Cleanroom doors and pass-throughs must allow contamination-free entrance and exit areas for both employees and supplies.
Finally, the cleanroom systems — including HVAC, HEPA filtration, and airflow — must work together to change the air effectively and prepare the employee for entrance into the cleanroom environment. In some sensitive applications, a dedicated HVAC system and fan/filter units may be necessary to capture particles during the cleanroom gowning procedure to keep them from entering your medical cleanroom.
Is your gowning room prepped to allow for maximum efficiency and minimum contamination? Angstrom Technology designs, builds, and installs secure and controlled cleanroom gowning rooms. We can help make sure your space is helping you reach your stringent classification requirements and eliminating contaminants wherever possible. For more information, give us a call or reach out online.
Obviously, your cleanroom’s construction and air filtration system are critical factors in keeping your cleanroom contamination-free, but so is what people wear in the cleanroom. People and fabrics are major sources of contaminants, and it’s crucial your control those sources with proper attire. Here’s what (and what not) to wear in a cleanroom:
Do’s:
Hoods
Hair Covers
Coveralls
Intersuits
Boots or shoe covers
Facial Covers
Gloves
Frocks
Depending on the classification of your cleanroom, there may be different requirements for the garments you have to wear. For instance, an ISO 3 Class (Fed Std. Class 1) cleanroom will likely require all of the garments listed in the “do’s” above, and will likely require that those garments be changed for new or cleaned ones every time you enter the cleanroom, whereas an ISO Class 5 cleanroom will require most of those garments, to be changed every day, and an ISO Class 8 cleanroom will require only some of those garments and that they be changed every two weeks.
Don’ts:
Makeup
Long hair (uncovered or not pulled back)
Fibrous sweaters or materials that shed
Materials that cause static
Dirty clothes or shoes
Extremely loose or baggy clothing
Shorts, tank tops, or other clothing that has cutouts or exposes skin
The “don’ts” here are don’ts because these items can bring contamination into the cleanroom. Dirty clothes and shoes are the most obvious of these contaminators, but a lot of contamination can come from the skin and hair cells we lose every day without us even knowing. Makeup can also shed from the skin and cause contamination, as can the fibers from clothing.
If you’re updating your current cleanroom, or starting from scratch, call the experts at Angstrom Technology.
If you have a cleanroom, you probably already know that humans are the biggest source of cleanroom contamination. The fact is that you do need people in the cleanroom to be able to manufacture your product. This means that your employees have to be gowned properly in order to reduce the amount of particles that are released into the air inside your cleanroom. The difficult part is deciding how they should gown, and ensuring that all employees are properly gowned, at all times.
Depending on what type of cleanroom you have, your employee requirements for gowning will be different. In some cases, they may just have to put on a lab coat and goggles, where in others they’ll need a full bunny suit. Generally, these requirement correspond with the level of cleanliness your cleanroom has to meet. The higher the standards, the more gear your employees will have to wear.
Once you know what your employees are required to wear, you can easily design a protocol for them to follow. It’s a good idea to keep a mirror in the gowning station, so employees can make sure garments are properly tucked in. You may also post a picture of someone properly gowned, as a “how to” reference for employees.
Here is a general list of things to consider when teaching employees proper gowning technique, to help you establish a simple, step by step process that your employees can follow every time they enter the cleanroom:
Remember that proper cleanroom attire starts outside the gowning room: Employees should be discouraged from wearing makeup, jewelry, hairsprays or perfumes, as these can all give off unnecessary particles and fumes, endangering the balanced state of your cleanroom.
Consider footwear: It may be a good idea for employees to have shoes dedicated only to the cleanroom, in the interest of minimizing contamination. If employees change shoes before even entering the gowning room, you’re minimizing the amount of dirt and dust particles tracked into the cleanroom.
No food: While this may seem like a no-brainer, make sure you’re reminding employees never to eat in the cleanroom. It may seem like a hassle for them to leave for lunch, and then redo the entire gowning process, but it’s a greater concern to have any kind of food or gum in the cleanroom. It’s a good idea to put up a sign outside the door to remind anyone entering the cleanroom of this rule.
Top to bottom gowning: When you’re developing your gowning protocol, it’s important to know that gowning should be done from top to bottom. That means that employees should start with hoods, then move to tops, then pants, then shoe covers. This method of dressing prevents any particles from falling down to already-gowned pants or booties.
Don’t touch: Employees should be aware that most cleanliness violations happen as a result of a garment being touched by dirty hands, or the floor. You should stress the importance of regularly washing and drying hands and gloves, as well as ensuring that garments do not touch the floor. A good way to minimize these issues is to make sure that surfaces are ultra-clean, and that no-touch washers and dryers are readily available.
Minimize motion: Believe it or not, people emit thousands of particles a minute even when they’re dressed in cleanroom gowning gear, and sitting still. As soon as people begin to move, that number of particles increases exponentially. This is why both your gowning room and your cleanroom itself, should be set up to minimize movement as much as possible.
With these considerations in mind, it shouldn’t be too difficult to come up with a thorough, step-by-step gowning procedure for your employees. Once you design the protocol, it’s important to make sure you train, and retrain it. Your personnel should attend a formal training program, but don’t stop there. Post reminder posters outside the gowning room, and make sure that your employees understand how important the gowning process is to maintaining the standards of your cleanroom. The best way to keep your cleanroom clean is to have a unified program for gowning procedure that everyone follows.
If you’re in need of gowning supplies, or if you’re looking for more information on cleanrooms, give the experts at Angstrom a call! We’ve been in the business for more than 20 years, and design, repair, and supply every kind of cleanroom. At 888-768-6900 we’re here to help answer any cleanroom question.
GET IN TOUCH
Angstrom Technology 3509 3 Mile Rd. NW Suite 3 Grand Rapids, MI 49534 Phone: 888-768-6900 Fax: 616-866-0080
