Disinfectant efficacy testing & validation

RSSL can provide analytical support for disinfectant testing and validation, as well as expert consultancy to help determine an appropriate disinfectant programme.

 

The EU GMP Annex 1 regulations emphasise the importance of sanitation within clean rooms, highlighting that they should be cleaned thoroughly in accordance with a written programme.

 

As a result, the design, validation, and implementation of a documented and approved disinfectant programme must form a key part of any pharmaceutical production area qualification. One vital element of these programmes is disinfectant efficacy studies or disinfectant validation. These are required to demonstrate that the disinfectants used on any surfaces within the manufacturing environment are effective at removing or inactivating microorganisms.   

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Disinfectant validation

For disinfectant validation, BS EN 13697 is usually considered the preferred standard. Testing to this standard can be performed in triplicate against your required surfaces, for predetermined contact times, using pharmacopeia standard organisms.  

 

RSSL has the capabilities to perform analysis on any specific isolates you may have found in your facility, that you want to include as part of the validation.

 

We can also provide consultancy to help determine your disinfectant programmes, and perform suspension disinfectant studies to determine the efficacy of disinfectant products such as hand washes, soaps and hand sanitisers. 

Standard testing

In addition to BS EN 13697, we are also able to test to the following standards: 

 

  • BS EN 1040  
  • BS EN 1275  
  • BS EN 1276  
  • BS EN 1650  
  • BS EN 13727  
  • BS EN 13624  
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