Production in the Grade C & D cleanroom

Chemical substances

Grade C & D

Production in the Grade C & D cleanroom according to §13 of the German Medicinal Products Act (AMG) under GMP conditions. 

In our cleanroom production, we rely on perfect interaction between technology and people. The production of pharmaceutical media uses technical equipment that meets the highest standards.
Production uses technical equipment that meets the highest standards. Depending on the medium to be manufactured, batch sizes of up to 5,000 litres can be produced in stainless steel or PVDF batch tanks. Validated manufacturing processes enable homogeneous and reproducible quality for each individual batch produced. What sets our pharmaceutical production apart is the handling of hazardous substances in the cleanrooms.

Filling, decanting, dilution, mixing

Our Services 

We are one of the few companies that can also handle hazardous substances in the cleanroom and produce innovative, flexible solutions for our customers in the pharmaceutical industry. We are geared towards the pharmaceutical needs of tomorrow and offer solutions for the pharmaceutical, biotech and medical device industries according to individual specifications.

Quality Assurance System

There are no compromises when it comes to quality.

Continuous improvement

  • Management review
  • Complaints procedure
  • Product quality review (PQR)
  • QA check BRR
  • Supplier and service provider qualification
  • Audit system
  • Training system

Risk-based management

  • Change control system
  • Deviation management
  • OOS system
  • CAPA system
  • Risk management according to ICH Q9

Qualification and validation according to Annex 15 EU GMP Guidelines

  • Room and plant qualification
  • Software validation
  • Process, cleaning and method validation

Chemical substances

Production of Liquid Substances

  • Mixing tanks: Plastic and stainless steel: 2000 l and 5000 l
  • Magnetically coupled mixers
  • Tanks with integrated scales for direct weighing of ultrapure media AP and WFI
  • Cleaning-in-place (CIP) of containers and product lines
  • Direct addition of solids and liquids
  • Can be blanketed with nitrogen
  • Online temperature measurement
  • Online measurement of pH level
  • Direct filling and weighing of media
    • Container filling from 1 l to 20,000 l  
    • Single-use bags from 500 ml to 1000 l
    • Small containers: 5 l - 25 l | up to 600 l/h
    • Drums and IBCs: 60 l - 1000 l | up to 5000 l/h
    • Tankers: up to 20,000 l

Production of Solids

  • Weighing of solids
  • Mixing of solids up to 600kg
  • Filling and transfer of solids from 5 kg to 60 kg
  • Grinding and classification of powders and granules
  • Grinding and classification of solids


AP & WFI water for injection.

We produce purified water and water for injection according to EP/USP. In stainless steel and plastic tanks with a useful volume of up to 5,000 litres, versatile solutions and mixtures can be produced and filled in a wide range of container sizes.

Water for injection (WFI) performance data

  • Production: 500 l/h
  • Storage tank: 5,000 l
  • Extraction volume: max. 7,000 l/h
  • Specification (EP/USP)
  • TOC online: ≤ 500 ppb
  • Online conductivity: ≤ 1.3 µS/cm

Purified water (AP) performance data

  • Production: 4,000 l/h
  • Storage tank: 10,000 l
  • Extraction volume: max. 7,000 l/h
  • Specification (EP/USP)
  • TOC online: ≤ 500 ppb
  • Online conductivity: ≤ 1.3 µS/cm

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