Clean room qualification in aseptic production
Testo Industrial Services carried out the requalification of the aseptic production facilities as well as the calibration of the humidity, temperature and differential pressure sensors with measurement uncertainty assessment according to GUM for Pharma Stulln GmbH.
As an innovative pharmaceutical company, Pharma Stulln GmbH has been producing eye drops, nasal sprays and inhalation solutions aseptically for more than 30 years in its own product range and in contract manufacturing for well-known pharmaceutical companies. The production of pharmaceuticals is carried out in accordance with the AMG, AMWHV and EU GMP guidelines. Furthermore, the company manufactures medical products according to MPG and is certified for this purpose according to DIN EN ISO 13485.
The aim of this project was to ensure the cleanroom status of the aseptic production premises by means of requalification measurements and to demonstrate controlled environmental conditions for the production of perfect product quality. In addition to meeting the regulatory requirements, a pragmatic and cost sensitive approach was implemented as well as the integration of customer-internal resources in the structuring and processing of the qualification measures.
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- Calibration of humidity, temperature, and differential pressure sensors with measurement uncertainty consideration according to GUM
- Proof of compliance with cleanroom classes A/B/C and D
- Filter leak test on terminal filters and LF units
- Differential pressure measurement on terminal filters
- Uniformity of the flow velocity
- (TAV flow) on LF units
- Air volume determination/air exchange rate
In addition to meeting the regulatory requirements, a pragmatic and cost sensitive approach was implemented as well as the integration of customer-internal resources in the structuring and processing of the qualification measures. The result was the holistic support of the customer in the area of clean room, calibration and qualification of the premises in the production.