Hospital disinfection webinar

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:

• Classify products and their applications as either a cleaner, sanitizer, disinfectant, or sporicidal agent.
• Know what contact times to assign based on the manufacturer label claims and your goals
• Understand the importance of sterility, stability, and SDS language for various products
• Understand validation of chemicals in cleanroom contamination control programs.

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:

Contact times

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: 

• What does your environmental monitoring data say about the type and number of organisms you are normally dealing with?
  • What type of organisms are captured in your environmental monitoring?
  • Where are they captured? ISO 5 Hoods, ISO 7 area, anterooms?
  • What is the number of CFUs?

• What does the product label say?
• Is the agent both a sanitizer and a disinfectant?
• Is the agent a disinfectant and a sporicidal agent?

• Should I use the sanitizing contact time or the disinfecting contact time?
• USP<1072> says facilities only need to show a 3log reduction of vegetative bacteria and 2log reduction of spore formers in a cleanroom environment. 

Surface compatibility 

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:

• Alcohols: low residue (be aware of volatile organic compounds [VOC] risks)
• Quaternary ammoniums: low residues (may require quarterly cleaning to remove)
• Hydrogen peroxide: low residues (be aware of Volatile organic compounds [VOC] risks)
• Sodium hypochlorite: high residues (can oxidize stainless steel and other surfaces)
• Hydrogen peroxide/peroxyacetic acid: residue level depends on formulation and percentages of active ingredients (has the potential to oxidize surfaces at higher concentrations)
• Phenolics: high residues (Veltek does not suggest phenolic use as most phenolics have been banned in Europe)

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:

• SDS language and bottle labels for ingredients in mixtures
• Individual protection measures and personal protective equipment (PPE)
• Other information (regarding health hazards, fire hazards, physical hazards and reactivity)

Want to learn more about cleanroom SOPs for hospital compounding facilities?

Watch the webinar for a complete discussion of the most important factors to consider when writing SOPs! If you need help with developing cleaning logs, contact us for a sample cleaning log!