RABS and isolator: VHP bio-decontamination to meet Annex 1 requirements

VHP to comply with Annex 1 requirements for bio-decontamination of RABS and isolators

VHP biodecontamination in pharma industry

Vapor-phase hydrogen peroxide (V-PHP or VHP) bio-decontamination is a process of surface sterilization that has been extensively validated and used in the pharmaceutical industry for many years.

In fact, VHP is one of the most commonly used sporicidal agents for bio-decontamination of cleanrooms, isolators, RABS and other controlled environments.

Biodecontamination in Annex 1

Annex 1 of the European Union’s Good Manufacturing Practice (GMP) guidelines sets out the requirements for the manufacture of sterile medicinal products. Annex 1 includes specific requirements for the design and operation of cleanrooms and other controlled environments, including RABS systems. These requirements cover areas such as environmental monitoring, personnel and material flow, contamination control and bio-decontamination procedures.

Bio-decontamination is widely mentioned in chapter 4 – Annex 1.
As explained in the Annex 1 glossary, bio-decontamination is intended to be a process able to eliminate all biological contamination from exposed surfaces via use of a chemical sporicidal.

The first time this word is mentioned is in chapter 4.20 (i) Isolators- point b:
“Key considerations when performing the risk assessment for the CCS of an isolator should include (but are not limited to); the bio-decontamination programme, […]”
This provides immediate evidence that this process is extremely critical for any isolator working in aseptic processes.

In chapter 4.21 (ii) the bio-decontamination process is also mentioned as alternative to sterilization:
“For RABS, gloves used in the grade A area should be sterilised before installation and sterilised or effectively bio-decontaminated by a validated method prior to each manufacturing campaign. …”
In fact, a properly validated bio-decontamination process can achieve, on exposed surfaces, the same result as a sterilization process (e.g. 6 Log reduction on most resistant microorganism Geobacillus stearotehrmophilus).

V-PHP is also mentioned in the Annex 1, specifically in chapter 4.36: “Where fumigation or vapour disinfection (e.g. Vapour-phase Hydrogen Peroxide) of cleanrooms and associated surfaces are used, the effectiveness of any fumigation agent and dispersion system should be understood and validated”.

The key to successful aseptic manufacturing is to maintain a rigorous control of the microbiological contamination either in isolators, RABSs and cleanrooms. For this reason, Annex 1 pushes on routine bio-decontamination programs and specifies the implementation of properly validated methods to achieve this result.

This is also well mentioned in chapter 4.22 (ii) where Annex 1 specifies about RABS bio-decontamination: “The sporicidal disinfection should include the routine application of a sporicidal agent using a method that has been validated and demonstrated to robustly include all areas of the interior surfaces and ensure a suitable environment for aseptic processing.”

Validation of proper distribution of sporicidal agent, as well as assurance of a proper Log reduction compatible with aseptic environment, are particularly important in RABS Bio-decontamination as mentioned in the regulation.

VHP meets Annex 1 requirements for RABS, isolator and cleanroom bio-decontamination

Vapor-phase hydrogen peroxide (V-PHP) is the perfect solution for complying with all Annex 1 requirements for bio-decontamination of isolators, cleanrooms and RABS as it provides:

Microbial efficacy
: Annex 1 requires that the isolator and RABS are thoroughly decontaminated and that there is no evidence of microbial contamination after the decontamination process. VHP bio-decontamination is capable of achieving the same target of sterilization on exposed surfaces, being able to provide a consistent and reproducible 6 log reduction on most resistant microorganism (Geobacillus stearothermophilus).

: Annex 1 requires that the decontamination process is validated to ensure that it is effective in removing or destroying microbial contaminants. VHP bio-decontamination can be easily validated as it is able to reach all difficult areas and provide reliable results over time also in complex layouts.

Minimizing the risk of product contamination: Annex 1 requires that the bio-decontamination process be designed to minimize the risk of product contamination. H2O2 vapor leaves no residues behind demonstrating to be in full compliance with this requirement.

: Annex 1 requires that the decontamination process is carried out safely, with appropriate consideration given to the health and safety of personnel and the environment. VHP is a perfectly safe and environmentally friendly sporicidal agent as it turns into oxygen and water at the end of the decontamination process.

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