The production of sterile pharmaceuticals and medical devices in clean rooms is a legal requirement
Cleanrooms are used for production and packaging of pharmaceuticals, sterile active ingredients and medical devices. Depending on the criticality of the scheduled process, different requirements from the central regulations such as the EU GMP guidelines (e.g. Annex 1) and ISO standards such as DIN EN ISO 14644, VDI 2083 or DIN EN ISO 13485 must be followed. The aim of the prescribed limits inside the room for air purity, temperature and humidity is to avoid contamination of the products by particles and germs. Possible sources of contamination can be personnel, machines, raw materials and media used.
When designing cleanrooms, GMP requirements for hygiene design must be taken into account in addition to technical issues in order to minimize potential sources of contamination. For example, attention must be paid to smooth, easy-to-clean designs for walls, ceilings, floors and installations, and a suitable airlock and changing room concept must be drawn up.
Valicare supports your company in the creation or design review of the cleanroom concept suitable for your special process, taking into account the applicable standards and regulations. We advise you at an early stage during the design qualification and, if desired, prepare the user requirement specification. We accompany you until the acceptance of the plant and beyond that, if requested, also during operation.
Qualification of clean rooms and isolators
After construction and commissioning, the cleanrooms must be qualified to prove their suitability for the intended purpose. A large number of tests, such as cleanroom classification, filter leakage tests or checks of the differential pressure cascade, air exchange rate and flow profiles (smoke study), are required and prescribed in the relevant regulations, e.g. EU-GMP Guideline Annex 1, FDA Guidence for Industry, Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice and ISO 14644.
We offer comprehensive service for the GMP-compliant qualification (DQ, IQ, OQ, PQ) of your facilities and premises. We perform the tests in a GMP-compliant manner and prepare the risk-based qualification plans and final reports for you.
In addition to cleanroom services, Valicare, as a wholly owned subsidiary of Syntegon Technology GmbH, a manufacturer of isolator and biodecontamination systems, offers consulting and practical implementation of process development and validation for isolators (filling and compounding).
Clean room operation
For the ongoing operation of cleanrooms, numerous requirements need to be followed. Without appropriate standard operating procedures (SOPs) for the cleanroom, there is still a high risk of contamination of the products. Personnel must also be trained to ensure GMP-compliant cleanroom operation.
Valicare has successfully created behavior concepts for cleanrooms in a large number of projects. We have already proven concepts including the necessary work instructions (SOPs), which we can promptly adapt to your needs. We also like to train your employees on the following topics:
- Behavior in the clean room
- Dressing procedure
- Hygiene concepts
Maintenance and requalification
To ensure that the cleanroom continuously complies with the specifications, maintenance and calibration as well as requalification are required by the regulations.
The scope and intervals for these activities are determined by the ventilation and cleanroom technology used, the cleanroom classes, and the regulations and standards specific to your company.
Likewise, regular proper cleaning must be performed by specially trained personnel to consistently minimize contamination on surfaces.
We advise you in the preparation of an appropriate cleanroom concept and/or work instructions for requalification, maintenance and calibration as well as the development of a cleaning concept. At regular intervals or flexible and promptly we carry out the necessary requalification activities for you.