Key factors to consider when writing hospital compounding facility SOPs:
A guide to cleaning, disinfecting, using sporicides and logging daily and monthly cleaning
As a pharmaceutical product distributor, helping customers choose the right products and develop contamination control programs for their cleanrooms is our priority. We recently hosted a webinar with Veltek Associates, a leading manufacturer of pharmaceutical contamination control products. The webinar provides valuable guidance and clarity on USP <797> guidance on pharmaceutical compounding sterile preparations, particularly for hospital compounding facilities.
After watching the webinar, you will be able to:
You can watch the full webinar here or read this blog for highlights.
Cleanroom product terminology
When it comes to writing hospital cleanroom SOPs, it’s important to know the difference between cleaners, sanitizers, disinfectants, sporicidal agents and sterilants. Each product plays a different role in cleanroom disinfection.
In the webinar, we discussed the following terms in detail:
Cleaning Agent: An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms.1 EPA regulates cleaning products only if they sanitize or disinfect2 (one-step cleaners and disinfectants).
Sanitizing Agent: An agent for reducing, on inanimate surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria.1 EPA requires manufacturers to prove a 3 log (99.9%) reduction of microorganisms for EPA sanitization label claims.
Disinfectant: A chemical or physical agent that destroys or removes vegetative form of harmful microorganisms when applied to a surface.1 EPA requires manufacturers to prove a 6 log (99.9999%) reduction of microorganisms for EPA disinfection label claims.
Sporicidal agent: An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms. 1
Sterilant: An agent that destroys all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. 1
1: Definition from USP<1072>
2: www.epa.gov discusses the difference between products that disinfect, sanitize and clean surfaces.
Watch the webinar for a full discussion on EPA registration requirements for these contamination control products!
Key factors to consider when writing hospital cleanroom SOPs
Developing SOPs (standard operating procedures) for your hospital cleanroom facility doesn’t have to be a daunting task. The following factors are among the most important to consider when writing SOPs:
Although contact times are listed on product labels, each cleanroom is unique. There are several factors that will help you select the shortest contact time to maintain workflow and protect your work surfaces from oxidation and residue buildup.
When writing SOPs, answer the following questions:
All sanitizing and disinfecting products leave behind a residue; some products leave more of a residue than others. When in doubt, check with the product manufacturer. They should be able to provide you with surface compatibility documentation for every product.
We discuss surface compatibility in depth in the webinar. Below is a general overview of compatibility of common products:
Frequency of application
In the webinar, we discuss guidance and new categories from USP for cleaning and rotation schedules. We include a chart detailing site, frequency of application, applicator, mode of action and recommended products.
Sterile vs. non-sterile
Proposed revisions to USP<797> state that disinfects and sporicidal agents must be sterile within the PEC. In areas outside the PEC, they should be sterile. According to USP, “must” indicates a requirement and “should” indicates a strong requirement. When selecting products, consider the risk of using a non-sterile product in the PEC, and consider if it is worth it to have two SKUs and multiple products in your SOPs.
Chemical stability and sterility once opened
Determining the chemical stability of a product is easy for manufacturers to document and provide to end users. Most manufacturers will be able to provide data for at least 30 days of in-use expiry once a product is opened. Typically, bottled disinfectants and sporicides are stable for ~30 days, bottled alcohols are stable for ~60 days and aerosol cans are stable for up to three years.
Determining sterility once opened is more difficult, as it depends on the user’s risk tolerance based on storage and product handling. Sterility of sterile water is particularly difficult to determine, as there are no active ingredients.
When in doubt, refer to the manufacturer’s documentation for determining an in-use expiry period for all products.
SDS language and PPE requirements
In the webinar, we discussed where to find guidance in USP<797> about:
Want to learn more about cleanroom SOPs for hospital compounding facilities?