Is your Pharmaceutical Clean Room compliant with the Biocide Disinfectants Product Regulations?


The Biocidal Products Regulation (BPR), Regulation 528/2012, supersedes the Biocidal Products Directive (BPD) regulations. BPR concerns the placing on the market and use of biocidal product. The text was adopted on 22 May 2012 and was applicable from 1 September 2013, with a transitional period for certain provisions. It repeals the Biocidal Products Directive (Directive 98/8/EC).

The regulations cover sterile disinfectants and non-sterile disinfectants commonly used within pharmaceutical grade cleanrooms.

A biocide is defined in the European legislation as a chemical substance or micro-organism intended to destroy, deter, render harmless, or exert a controlling effect on any harmful organism by chemical or biological means.

Biocides are used to protect humans, animals, materials or articles against harmful organisms such as bacteria, by the action of the active substances contained in the biocidal product. They are widely used in high grade pharmaceutical cleanrooms to disinfect equipment such as isolators and laminar flow cabinets, as well as surfaces. They are also widely used to disinfect product and equipment entering the clean room by transfer.

The regulations aim to ensure a high level of protection for humans and the environment.

All biocidal products require authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved.

It is also a requirement for biocides to be registered with the European Chemicals Agency (EHCA) and products must be labelled in accordance with the Classification Labeling and Packaging Regulation (CLP)

The consequence of non compliance will be disruptive and expensive for both suppliers and end users. Failure to comply may incur fines and possible criminal proceedings depending on the severity of the non compliance.

Cleanroom supplies stock a range of high quality, BPR compliant and highly effective sterile disinfectants and biocides. In addition to regulation compliance, our range include:

  • Powerful, BPR compliant disinfectants to eliminate surface contamination, including C.Difficile spores, MRSA, bacteria and viruses.
  • Combine anti-microbial efficacy with short contact times, making it suitable for use in isolators, cleanrooms, adjacent preparation areas and transfer disinfection.
  • Compatibility with a variety of typical cleanroom materials helps to avoid surface corrosion.
  • A range of rapid action, sterile rotational Sporicidal, Bactericidal and Fungicidal disinfectants with full documentation.
  • Sprays, capped and impregnated pouch wipe formats.
  • WFI quality Sterile Water, double bagged and gamma irradiated. Suitable for Grade A use, in either spray or capped format.

We have a wealth of experience, product information and data, so if you need assistance or would like to learn more about our products, please feel free to contact us.

With Cleanoom Supplies, you can rest assure that you are fully compliant.

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