In the Pharmaceutical and associated industries, the subject of disinfectant validation is attracting ever increasing attention from regulatory bodies such as MHRA, HPRA and FDA.
Companies are now expected to be able to demonstrate conclusively that their disinfectants of choice are effective under the conditions in which they are used.
A recognised approach to disinfectant validation is to follow the CEN (European Committee for Normalisation) Technical committee 216 work programs which provide a systematic approach to the validation of disinfectant efficacy.
A number of BS EN methods have been issued as a result of the CEN work program. The literature defines in detail how disinfectants should be tested against a range of type cultures under controlled conditions. There are clearly defined pass criteria and results are expressed as either pass or fail. All the methods include rigorous validation requirements which are performed in parallel to the test itself.
Test In-house or Outsource?
There are two compelling reasons for outsourcing disinfectant validation:
- Disinfectant testing has a long, steep learning curve and can be extremely time consuming for those not fully familiar with the methods.
- For most companies, the testing is either one off or occasional. This together with the investigative nature of the work means there is no understanding of what results may be expected. Daniels Pharmaceutical laboratories perform disinfectant testing on a daily basis, for many customers, and as a result we have a database of results which we use to check for out of trend results and offer advice should disinfectant performance be disappointing.
BS EN Methods
The CEN approach has three phases:
|Phase 1||Basic bactericidal and fungicidal activity.||BS EN 1040*
BS EN 1275*
BS EN 14347
|Phase 2||Step 1||Quantitative suspension testing to evaluate bactericidal, fungicidal and sporicidal activity.||BS EN 1276*
BS EN 1650*
BS EN 13704*
BS EN 13624*
BS EN 14348
|BS EN 1656*
BS EN 1657*
BS EN 14204
|Phase 2||Step 2||Surface testing||BS EN 13697*||BS EN 14561*
BS EN 14562*
BS EN 14563
BS EN 1499*
BS EN 1500*
BS EN 12791
BS EN 16615**
|BS EN 14349|
|Phase 3||Field Trials – yet to be developed|
* UKAS Accredited Standard
** UKAS Accreditation Pending
At Daniels Pharmaceutical we are familiar with all these and many other disinfectant test methods.
However it is the wider application of the standard BS EN methods that is the key to a thorough, coherent disinfectant validation program.
Wider Application of the BS EN Methods
The BS EN methods themselves are of value as a means of determining the efficacy of a disinfectant under controlled conditions. However, in normal working conditions, environmental organisms are encountered which can provide a greater challenge to disinfectant products.
The nature of the BS EN methods is such that they can be adapted to form the basis of more informative studies into the performance of disinfectants in practice. This can yield valuable information about the comparative performances of a number of products and the adapted methods facilitate studies of the effects of changes in product concentration, contact time, test temperature and the use of water produced in your facility, all of which help to evaluate your specific in house cleaning procedures.
Handwashes and Handrubs
BS EN 1499 and BS EN 1500 are specifically designed to test handwashes and handrubs. Both methods involve the use of a panel of volunteers who use the product under test and a reference material.
BS EN 12791 evaluates the sustained action of surgical hand disinfectants.
BS EN 14348 is a quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (Phase 2, Step 1).
BS EN 14204 is a quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants for instruments used in the veterinary area - Test method and requirements (Phase 2, Step 1).
BS EN 13623 Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems — Test method and requirements (Phase 2, Step 1)
Alternative Disinfectant Test methods
For companies not wishing to follow the CEN approach, a number of alternative methods are available for the evaluation of disinfectant products, including but not limited to AOAC, ASTM, EPA/OECD methods.