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Cleanrooms in the GMP Area
Cleanrooms in the GMP Area

Production of sterile pharmaceuticals and medical devices in cleanrooms

Valicare offers you exactly the services you need to ensure the sterility of your cleanrooms for the manufacture and packaging of pharmaceuticals, sterile active ingredients, and medical devices.

Depending on the criticality of the process, different requirements from 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 apply. The aim of the defined limits for air purity, temperature, and humidity inside the room is to avoid product contamination through particles and germs. Possible sources of contamination can be personnel, machines, raw materials and media.

In addition to technical issues, GMP requirements for hygiene design must be considered in cleanroom design to minimize potential sources of contamination. For example, close 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 established.

Valicare supports you 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 design qualification and, if desired, prepare the user requirement specification. We accompany you right through to plant acceptance and, if requested, also during operation.

After construction and commissioning, 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 defined in the relevant regulations, e.g. EU-GMP Guideline Annex 1, FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice, and ISO 14644.

The revision of Annex 1 has introduced changes especially concerning isolators and cleanrooms.

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.

Valicare offers GMP-compliant processing of individual subtasks, comprehensive support, or complete execution and documentation of the qualification.

Our parent company Syntegon is a well-known manufacturer of isolator and biodecontamination systems. This enables us to consulting and practical implementation of process development and validation for isolators (filling and compounding).

Numerous requirements must be fullfilled in the ongoing operation of cleanrooms. Without appropriate standard operating procedures (SOPs), the risk of product contamination remains high. Staff must also be trained to ensure GMP-compliant cleanroom operation.

Valicare has successfully created behavior concepts for cleanrooms in numerous projects. We have proven concepts including work instructions (SOPs), which we can promptly adapt to your needs.

We can also train your employees on the following topics:

  • Behavior in the cleanroom
  • Dressing procedure
  • Hygiene concepts

To ensure that the cleanroom continuously complies with the specifications, regulations require maintenance and calibration as well as requalification.

The scope and intervals of 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 surface contamination.

We will be happy to advise you in preparing an appropriate cleanroom concept and/or work instructions for requalification, maintenance, and calibration as well as in developing a cleaning concept. We will carry out the required requalification activities for you, either in regular intervals or flexibly according to your needs.

Free first consultation now!

Free first consultation now!

 

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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Our Company

Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.