- Production-, storage- and distribution-systems for für pharmaceutical high purity media, especially water (purified media, WFI, pure steam) and process gases as wie compressed air and nitrogen.
- CIP-, WIP- and SIP- systems
- Formulation systems for liquids
- Formulation systems for the production of suspensions and emulsions
- Cleaning and sterilization system with ozone, hydrochloric acid, steam or hot water pressure
Qualification and Validation
The product manufacturing in the pharmaceutical or in the food industry are subject to increasingly detailed regulations of athorities and have to comply with FDA and European standards.
These investments have to be validated. As a plant operator, therefore you have to verify your entire process structure that it operates to specifications and is reproducible.
In all levels of qualification, we are prepared for the mentioned requirements. Wellmann Engineering is your competent advisor for Design Qualifications (DQ), Installation Qualification (IQ), for the Operational Qualification (OQ ) and Performance Qualification (PQ).
The Design Qualification describes your entire process planning. So, we ensure that your requirements are met completely and that all parent guidelines and detailed regulations of athorities are observed. Concrete Standard Operating Procedures ( SOPs) ensure not only the GMP according handling, but also maintain the qualified status.
- Execution and documentation of necessary tests
- Vendor- and product-neutral qualification of components and systems as well as creating qualification plans and reports
- Validation and documented evidence of critical procedures and processes
- Customer-orientated management of the documetation process and the documentation structures