FAQ: Which Test for Evaluation of Activity of chemical Disinfections are relevant for the Pharmaceutical Industry?

The current guidelines like the FDA Guidance for Industry “Sterile Drug Products Produced by Aseptic Processing” or the Annex 1 of the EU GMP Guideline stipulate the use of disinfectants with an evaluated efficacy against microorganisms. In many pharmaceutical companies, the responsible personnel for cleaning and disinfecting in pharmaceutical production and laboratory are faced with the question, by which national or international standards a disinfectant must be tested to assure the needed activity against bacteria, fungi, viruses and bacterial spores.

In different European countries, national standardised tests like VAH ( former DGHM) in Germany or AFNOR in France have been existing since more than 20 years. To harmonise the assessment of regulatory bodies, the European Committee for Standardisation (CEN) and Technical Committee (TC) created the CT216 work programme, "Chemical Disinfectants and Antiseptics." This Test evaluated the activity of chemical tests in 3 phases:

• Phase 1
  Quantitative suspension test under unsoiled conditions for basic activity
• Phase 2
  Step1
  Quantitative suspension test under conditions representative of practical use
• Phase 2
  Step 2
  Quantitative Surface test under conditions representative of practical use
• Phase 3
  Field test under practical conditions

Today, both the national standards or the harmonised test can provide the necessary informative basis that is needed to select disinfectants for the use in pharmaceutical manufacturing or laboratory. For the near future, the CEN standards will become the basis in Europe  for the assessment of disinfectants in international operating companies.

Following you will find a table to get an overview about the most important tests:

The test for evaluation of activity against bacterial spores is described in EN 13704.

These tests will build the base for deciding what disinfectants are the right ones to use. However, special requirements like the testing against the germs from environmental monitoring in aseptic processing, necessitate further tests for the validation of disinfection processes.

The ECA education course FDA and GMP Requirements on cleaning and disinfection management in Munich, Germany, from 15-16 October 2009 provides you with an insight in regulatory background and practical implementation of cleaning and disinfection in pharmaceutical manufacturing.

Author:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)