This pharmacy cleanroom cleaning guide is an overview of the cleanroom chemicals, products, and tools and how they are typically used for compounding pharmacy applications. Each cleanroom and its applications have unique cleaning requirements. At no time should this guidance replace existing documents and procedures established by the pharmacy facility unless written permission is obtained from the facility manager. Consult your cleanroom standard operating procedures for protocols specific to your critical environment.
Cleaning and sanitizing ISO Class 5 (Class 100) cleanrooms such as compounding pharmacies and hospital pharmacies to meet USP Chapter 797 requirements requires consistently utilized protocols. While some USP requirements mean large investments of capital, cleanroom cleaning protocols can be implemented at a relatively low cost. However, proper apparel use and cleaning routines do require staff cooperation that is most easily earned through education and clear written procedures.
An understanding of how proper garbing and cleaning can provide immediate and substantial risk reduction is the key to adopting the needed changes.
This guideline is an overview of the cleaning and disinfection guidelines with a brief overview of monitoring cleanliness and sterility for cleanest ISO Class 5 to less-strict 8 cleanrooms. Federal standards mandate the number of particles equal to and greater than 0.5mm measured in one cubic foot of air for each class of cleanroom.
ESTABLISHING A CLEANROOM CLEANING ROUTINE
When a pharmacy cleanroom has implemented primary and secondary engineering controls and realized consistent use of the proper PPE and particulate-control measures, the weak link of cleaning procedures can break the chain of sterility and cleanliness. Lapses in cleaning protocols result in viable particles, those of a biological nature, to void asepsis or allow infiltration of non-viable particles that while not biologically active, serve as transportation for micro-organisms.
For some pharmacy cleanrooms, a professional cleanroom cleaning service can assist with keeping environmental hygiene at its highest. But in many pharmacies, the staff cleans the controlled environment. In hospitals, the environmental services department may have this responsibility at least partially as some hospital pharmacies utilize their environmental services department into weekly or monthly cleaning cycles, while the cleanroom staff complete daily cleaning protocols.
The most important aspect is not who cleans the pharmacy, but rather what they know. Detailed cleaning protocol training is vital. Download a high-level sample of an ISO5 compounding cleanroom cleaning routine. Periodic supervision of the cleaning in progress as well as record-keeping of the cleaning routine are required to ensure the cleaning is performed as planned and documented for compliance with USP requirements.
CLEANROOM CLEANING PROTOCOLS FOR SPECIAL SITUATIONS
When bringing a cleanroom online for the first time or if contamination is found, especially with tough sporicides, your designed cleaning protocol can be performed multiple times to achieve the level of cleanliness and sterility needed for your ISO 5 pharmacy.
WHAT TO USE TO CLEAN YOUR PHARMACY CLEANROOM
Cleaning and sanitizing agents are critical to the process. Cleaning and disinfecting are two separate actions that must be performed in a clean then disinfect order to thoroughly clean a facility.
CLEANING
Cleaning using a detergent or surfactant solution is for removing dirt, grime, grease, and particulates from a surface. Disinfection is the application of a chemical with germicidal properties to eliminate micro-organisms. Cleaning comes before disinfection. It is a bit like cleaning at home. If you do not remove the crumbs and spills from the kitchen counter with a wet paper towel, then disinfecting with a bleach-based spray is less effective and takes more product to ensure sanitization. It is the same in a cleanroom. For example, use a dry microfiber mop or sticky roller to remove debris from the floor, the most contaminated part of your environment given that you walk on it and the air circulation is designed to force contaminants down. Then, after cleaning the floor, apply the disinfectant thoroughly with a mop.
DISINFECTING
Sanitization is vital to a USP 797-compliant compounding pharmacy or hospital pharmacy. But it is one of the areas that can be very confusing when designing your cleaning protocols. For one thing, there are many types of disinfectants. They can be grouped into two general categories: oxidizing and non-oxidizing agents. Each category kills different types organisms: oxidizing agents are broad spectrum with the power to kill spores, the toughest of micro-organisms to eradicate while non-oxidizing agents are organism specific. Note that the more general oxidizing agents are non-specific creating risks for humans cleaning so if they are part of your protocol, use greater caution to protect cleaning workers.
Non-oxidizing agents include:
Oxidizing agents include:
Isopropyl alcohol (IPA) is commonly used as a sanitizing agent for surfaces in ISO Class 5 compounding cleanrooms, but 3% hydrogen peroxide and 2% sodium hypochlorite (bleach) solutions also effectively sanitize. The Center for Disease Control (CDC) declares that a sodium hypochlorite solution of 500 ppm is effective against nearly all bio-contamination. Though many studies support bleach’s disinfectant and sterilant attributes, it does not possess the detergent action for cleaning away soil and residue.
Rotation of disinfecting agents is recommended to prevent the development of resistant microbes. For example, use a 2% bleach solution for 6 days followed by a detergent-based disinfectant on one day. The detergent-based cleaning day may need to be periodically varied to ensure that it is included in the weekly and monthly cleaning routines. Use of a sporicide is highly recommended as part of your monthly or quarterly cleaning cycles. This approach to cleaning solutions is economical as hard-surface disinfectants can cost 15 to 25 times more than bleach solutions.
Consult with manufacturers’ instructions and cleanroom consultants to ensure that your cleaners, disinfectants, and the tools used to apply and wipe them are all compatible. Cleaning agents’ purposes and how they are used vary greatly.
Some disinfectants rinsing after the contact time to remove residue. Appropriate rinses in ISO 5 areas include:
CLEANROOM SPILLS
For spills in the ISO Class 5 area, use a lint-free wipe to wipe away with sterile water or outside the ISO5 area, use tap water. Then follow with the cleaning agent specified in the SOP to prevent chemical reactions between pharmaceutical components and cleaning agents.
Note that spill prevention is a good practice such as using chemo prep mats to contain spills.
CLEANING SOLUTION PREPARATION
Following manufacturer instructions is critical to ensure that dilution, storage, applying, and handling of the cleaning agents does not reduce efficacy. The correct dilution ensures that surfaces such as floors, workbenches, and compounding equipment are not damaged as they work to sanitize effectively. Using highly caustic cleaning agents, even used properly, can over time result in pitting stainless steel, especially the stainless steel is not cleanroom-grade.
Material safety data sheets (MSDS) are available from cleaning solution manufacturers and your cleanroom supplier such as Cleanroom Connection. Note as part of USP compliance, MSDS must be kept onsite. Follow manufacturer instructions, keeping these common procedures in mind:
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