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Cleanroom qualification in aseptic manufacturing by Testo Industrial Services

Cleanroom qualification in aseptic manufacturing

Pharma Stulln GmbH.

Reference

Cleanroom qualification in aseptic manufacturing

at Pharma Stulln GmbH

As an innovative pharmaceutical company, Pharma Stulln GmbH has been producing eye drops, nasal sprays and inhalation solutions for more than 30 years for its own range as well as for well-known pharmaceutical companies as a contract manufacturer. The production of pharmaceuticals complies with the German Medicinal Products Act (AMG), German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV), and the EU-GMP guidelines. The company also manufactures medical products in accordance with the German Medical Devices Act (MPG) and is accordingly certified in compliance with DIN EN ISO 13485.

The aim of this project was to ensure the cleanroom status of the aseptic production facilities by re-qualification measurements and to verify the controlled ambient conditions for the production of perfect product quality. In addition to meeting the regulatory requirements, a pragmatic and cost-sensitive approach was implemented and the integration of internal customer resources in the structuring and execution of qualification measures.

Cleanroom qualification in aseptic manufacturing

Our scope of services

at Pharma Stulln GmbH

  • Calibration of the humidity, temperature and differential pressure probe with a measurement uncertainty consideration according to GUM
  • Verification of compliance with the 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) in LF units
  • Determination of air volume/air exchange rate

Cleanroom qualification in aseptic manufacturing

The result

at Pharma Stulln GmbH

In addition to meeting the regulatory requirements, a pragmatic and cost-sensitive approach was implemented and the integration of internal customer resources in the structuring and execution of qualification measures. The result was the integrated support of the customer in the area of cleanroom, calibration and qualification of the premises in production.

More assurance, better service for your GMP compliance

What set us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Testo Industrial Services

Our services at a glance

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