Cleaning, decontamination and sanitation

Other manufacturing procedures requiring validation include cleaning, decontamination and sanitation (CDS) procedures developed for specific items of equipment/processing areas. Of particular importance is the ability of such procedures to remove bioburden. This may be assessed by monitoring levels of microbial contamination before and after application of CDS protocols to the equipment item in question. 

The product contact surfaces in this environment are typically removed for cleaning however, in some installations, the sterilization, transfer, and reinstallation of the component feed hoppers present such difficulty that these systems are decontaminated in situ with a sporicidal agent, rather than removed after each use. These units should still be removed for cleaning and sterilization on a validated periodic basis to prevent the buildup of residues that might impact their in-situ decontamination or create particle control problems. All other product contact surfaces should be sterilized prior to each use. Nonsterilized items should not be allowed to enter the ISO 5 portion of the fill zone, and sanitization is essential for all nonproduct surfaces in the fill zone, as well as the surrounding background environment. 

If certain products are to be produced on a campaign basis, the layout and design of the premises and equipment shall permit effective decontamination by fumigation, where necessary, as well as cleaning and sanitizing after the production campaign. 

The Centers for Disease Control state that HBV can survive for at least one week in dried blood on surfaces so it s very important to clean and sanitize properly. Contaminated work surfaces must be decontaminated with a disinfectant following an emergency incident. Take into consideration the appropriate methods of decontamination based upon the location within the facility, type of surface, types of contamination, if any, and tasks or procedures being performed. 

For the pharmaceutical and food industries, surface finish is very important to enable effective cleaning and sterilization or sanitization. Equipment should be specified with a polished internal finish, possibly with electropolishing for critical applications, and designed with a minimum of crevices or dead spaces where dirt can collect. Welds must be finished to the same standard as the plates and ground flush with the internal surface and must be pinhole and crevice free. External surface finish may also be important for visual reasons and to enable cleaning down for surface decontamination in clean room locations. 

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