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Important Addition to Accepted Sterilisation Technologies for Indirect Product Contact Surfaces Announced at PDA Conference
Representatives of European Health Authority and Industry Experts Comment on Procedures for Surface Sterilising Indirect Product Contact Parts for Restricted Access Barrier Systems (RABS) and Associated Filling Lines
BASEL, Switzerland, (date) - The Parenteral Drug Association (PDA) recently held a Conference on “Advanced Applications of Isolators, RABS and Clean Rooms” 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 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 (UK) 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 6 log sporicidal reduction that can easily be designed to create an overkill situation. If the gaseous decontamination is also used for non-contact parts then 4 log sporicidal reduction may be acceptable, if followed and supported by a thorough risk assessment”.
Today the bench mark 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 most probably on 14 October 2010.
“I encourage everyone to watch out for these publications by visiting the PHSS and PDA websites for consultation," he concluded.
More details and essential information on these and other issues in pharmaceutical manufacturing will be given at the PDA Conference Parenterals 2010, held in Berlin, Germany, 26 to 28 October 2010. To book your place at the conference please visit www.pda.org/europe.
NOTES FOR EDITORS
Goals of the Conference were to clarify regulatory expectations and industry deliverables to successfully implement Isolators, Restricted Access Barrier Systems (RABS) and Clean Rooms in a pharmaceutical manufacturing environment. During the Conference, selection criteria for choosing the most appropriate manufacturing environment were presented and discussed. At a Round Table Discussion questions by participants regarding development, qualification, validation, and implementation in response to requirements put forward by the Annex 1 to the EU and the PIC/S GMP Guide were answered by Health Authority representatives coming from e.g. Swissmedic and other experts. Several operating options, e.g. for decontamination or stoppering had been identified and need to be followed up by industry and authorities. Those include definition of “Clean Process” versus “Aseptic Process” for the stoppering, capping and crimping unit operation for example. Capabilities and limitations of processes and procedures like gaseous, vapour phase decontamination, rapid viable and non-viable monitoring devices and process simulation practices by media fill exercises presented other topics of the debate. To capture what was discussed, a White Paper and a Technical Monograph on RABS definitions and specifications will be issued.
About PDA - Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.
About PHSS
The objectives of PHSS are to foster and advance, in the interest of public health, Pharmaceutical and Healthcare Science and Practice. PHSS aims to provide and disseminate to its members information concerning all aspects of pharmaceutical technology and product administration. In addition, it will foster and encourage a spirit of friendly co-operation among the members of the society and to promote favourable relations between its members and the medical, pharmaceutical, hospital and related health professions as well as to cultivate and maintain co-operative relations with governmental departments and agencies, medical, pharmaceutical and related health organisations, the academic community and compendial bodies and other branches of the pharmaceutical and other pertinent industries; and to originate and participate in co-operative enterprises and undertakings with them. To learn more about PHSS, visit www.phss.co.uk.
