Services
Environments, Systems and Process Validations
The international standards for the quality provide for validating all the productive and services processes,
for those whom eventual lacks can be discovered only after the use of the product.
The same normative explains that the sterilization, the packaging, the control of production areas
for the medical disposables are considered special processes and, for this reason, they ask for the validation activity.
A complete knowledge of the international normative and thirty years of experience in the sterilization field,
allow Bioster to have a technical team well prepared in special processes, plants and clean rooms validations.
Synergy between validation team and laboratory technicians increases the possibility to investigate
in the proper way also a large range of technical aspects in the production processes.
These abilities help Bioster to increase the range of services: qualifications (IQ, PQ and OQ)
for internal and customers plants, protocols of validation for special processes,
technical verification for sterilization plants, sterilization processes, rooms
with particles and microbiological controlled environment analysis to support the product certification.
These activities are run using modern instruments and methods which are the state of art and enable Bioster
technicians to connect with the different plants used by the customers.
The validation activity for a special process, as sterilization, the conditioning of a production area,
the packaging of a medical disposable or the preparation in sterile, ask for the development of a studied validation project.
The attention which Bioster puts in this sector allowed, since 1996, to certify these validation
and verification activities according to the European Community Standards EEC, for the different
kinds of products and to the quality guide lines in the different sectors:
MDD (93/42/EEC), EN ISO 9001, EN ISO 13485, 2001/83/CE, 2003/94/CE, GMP; Italian and European Pharmacopoeia, USP.
Bioster validation service offered to medical devices, pharmaceuticals, cosmetic, alimentary companies as well as, the public and private sanitary sector, includes:
• Qualification (IQ, OQ, PQ) and validation of sterilization plants and processes by ethylene oxide,
including also microbiological, biological and chemical analysis.
• Qualification (IQ, OQ, PQ) and validation of sterilizations plants and processes by electron beam, x
and gamma rays, including also microbiological, biological and chemical analysis.
• Qualification (IQ, OQ, PQ) and validation of sterilization plants and processes
for industries and hospitals by steam, including also microbiological, biological and chemical analysis.
• Qualification (IQ, OQ, PQ) and validation of area with particles and microbiological
environmental contamination, as clean rooms, laminar flow caps, surgery rooms,
including also microbiological, biological and chemical analysis.
• Qualification and validation of packaging systems,
including also microbiological, biological and chemical analysis.
• Qualification and validation of systems
for asepsi production for active priciples and medicines.
• Qualification and validation of washing, disinfections, decontamination and different kind
of sterilization systems, dry sterilizers, tunnels, depirogenerators, liofilizators, climatical rooms,
stability rooms, incubators and any other kind of equipment or plant used in the production
of medical devices, pharmaceutical, cosmetic or alimentary products.
The validation are according to International Normative and Guide Lines as,
EN ISO 11134, EN ISO 11135, EN ISO 11137, EN 17665, ISO 14644, ISO 11607, EN 868, ISO 14937, ISO 15883, ISO 1634
