With the review of GMP Annex 1, the bio-decontamination of barrier systems has certainly taken on a key role, but not all solutions available on the market offer the same answers in terms of results, process management and validation. In the article below, we are going to consider some aspects that should be evaluated before choosing the most suitable system for your aseptic process.
GMP Annex 1 and VPHP biodecontamination
Almost a year after GMP Annex 1 came into force, there are still several open questions and problems to be solved. From one hand, there are some aspects whose interpretation gives rise to debate within the pharmaceutical industry but, on the other hand, some messages emerge with the utmost clarity.
One of them is certainly the need to use the most advanced technologies on the market. It’s nothing new, since from the 2001 and 2003 versions of the document, the so-called “Marketing Authorization Holders” companies were required to use updated processing technologies. But, after the latest review of this document, it has become clear that this kind of choice is considered today as a crucial element for contamination control by identifying the use of isolators and RABS as a preferential choice in the drafting of the Contamination Control Strategy (CCS).
Restricted Access Barrier Systems (RABS) or isolators are beneficial in assuring required conditions and minimizing microbial contamination associated with direct human interventions in the critical zone. Their use should be considered in the CCS. Any alternative approaches to the use of RABS or isolators should be justified.
(GMP Annex 1, Premises 4.3, p. 06)
In this context, it appears clear that the engineering approach towards the barriers systems represents a key element of the contamination control strategy required by the document, so much that GMP Annex 1 identifies some critical points that should be specifically considered in the CCS drafting. Among them, there is also the bio-decontamination program.
Key considerations when performing the risk assessment for the CCS of an isolator should include (but are not limited to); the bio-decontamination programme, the extent of automation […].
(GMP Annex 1, Premises 4.20, p. 10)
The characteristics of the bio-decontamination process of the internal surfaces of barrier systems are defined in section 4.22 of the document.
The bio-decontamination process of the interior should be automated, validated and controlled within defined cycle parameters and should include a sporicidal agent in a suitable form (e.g. gaseous or vaporized form).
(GMP Annex 1, Premises 4.22, p. 11)
If the message contained in these two lines is quite clear, the same cannot be said for its practical application. The sentence “controlled within defined cycle parameters” contains several implications related to the performance and characteristics of the technology used. There are cycle parameters that should be taken into consideration and which strictly depend on the engineering process.
Furthermore, not all the solutions offer the same response in terms of results, process management and validation. Below are listed several useful considerations about GMP Annex 1 and VPHP biodecontamination in order to evaluate the right solution for any need.
