The Parenteral Drug Association (PDA) recently held a conference on 'Advanced applications of isolators, RABS and clean rooms'.
The conference was held with representatives from European health authorities, including Swissmedic and experts from industry, as well as the Pharmaceutical and Healthcare Sciences Society (PHSS).
During the debate, experts revealed ongoing discussions with European Health Authorities and FDA on acceptable procedures for surface sterilising indirect product contact parts.
Those discussions will lead to the publication of a white paper and later to a more detailed technical monograph.
A recurrent problem is the transfer of equipment and material into a RABS.
Equipment, like a stopper bowl used in an aseptic manufacturing process and operated in a RABS, needs to be sterile to prevent it from contaminating product.
Today, such indirect contact parts surface sterilisation is frequently performed outside the RABS and, hence, aseptic transfer of bulky and/or heavy equipment into the system presents a challenge and a risk.
If this operation could be performed in place, it would reduce contamination risk to a large extent.
'As contact between, for example, a stopper bowl and the product would be indirect, industry experts have suggested the use of automated gaseous, vapour phase, decontamination processes have a place between Traditional Sterilisation and Disinfection,' said James Drinkwater, process director with Bioquell and current Chairman of PHSS.
'In discussions with MHRA and FDA (USA) representatives, we have put forward hard data and justification that indirect product contact surfaces can be surface sterilised in place using an automated gaseous, vapour phase, decontamination process resulting in a six-log sporicidal reduction that can easily be designed to create an overkill situation,' said Drinkwater.
'If the gaseous decontamination is also used for non-contact parts then four-log sporicidal reduction may be acceptable, if followed and supported by a thorough risk assessment,' he added.
Today the benchmark for an automated decontamination process suitable for gassing in place (GIP) indirect product contact surfaces is hydrogen-peroxide vapour.
As a process that can be validated to achieve conditions of surface sterilisation, there are important prerequisites of Bioburden characterisation and validation of cleaning residues to ensure there is not a potential for cleaning and peroxide compounds that may be a chemical contamination to the product via indirect mechanical transfer.
Stainless steel is a mild catalyst to hydrogen peroxide, so peroxide will not exist on the surface but can compound with other chemical residues if present.
James Drinkwater announced that the white paper will represent a consensus position that was previously shared with representatives from MHRA and FDA, for example.
It is planned to be published in July 2010.
To give even more details on how to define, specify and operate the various RABS environments, a technical monograph will be released on 14 October 2010.
More details and information on these and other issues in pharmaceutical manufacturing will be given at the PDA Conference Parenterals 2010, held in Berlin, Germany, on 26 to 28 October 2010.
