Disinfection forms a fundamental part of any manufacturing facility
maintenance schedule as inadequate disinfection can have a direct impact
upon product quality and ultimately patient safety. As such,
disinfection and the use of disinfectants falls within the remit of cGMP
and must be controlled as such.
Over the last few years we have seen increased
scrutiny over disinfection practices by the regulatory authorities with
disinfection and disinfection efficacy testing requirements being
discussed in a number of regulatory documents such as:
- USA (cGMP and FDA Aseptic Processing Guide) 21 CFR 211.56b, 21
CFR 211.56c and CFR 211.113b
- USA (FDA Aseptic Processing Guide)
- USP (General Chapter <1072> Disinfectants and Antiseptics)
- Annex 1 to the EC Guide to Good Manufacturing Practice
Disinfectants available today can broadly be broken down into eight
categories. With each type of disinfectant having differing
properties and a number of factors affecting the efficacy of
disinfectants, careful consideration must be given when selecting
suitable disinfectants for a particular manufacturing environment and
process. It is therefore essential to have control of and
confidence in the different disinfectants being used throughout a
facility which can be achieved by validating the efficacy of each
disinfectant and the process of disinfectant application.
Cleaning is often wrongly confused with disinfection: cleaning
removes contamination from a surface but does not necessarily kill
bacteria, viruses, mould or fungi whereas disinfection removes
vegetative or non-endospore forming pathogens. For many companies
the disinfectant efficacy programme forms part of the overall ongoing
monitoring control programme which also gives consideration to
cleaning validation and
environmental monitoring.
Honeyman are helping an increasing number of companies with their
disinfectant efficacy programmes, providing a range of services
including;
- Facility and Supplier Audits
- Literature Searches
- Methodology Generation
- Criteria Definition and Protocol Generation
- Disinfectant Efficacy Testing, Data Analysis and Interpretation
- Report Generation
-
Training
- Troubleshooting
- Consultancy
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