CG Pharma Production

Chemistry in the cleanroom.

 

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 under cleanroom conditions

Grade C and D.

 

Filling, decanting, dilution, mixing – our production under Grade C and D cleanroom conditions makes us a specialised partner to the pharmaceutical industry.

We offer the service of this production at the Laatzen site. 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.

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

Purified water

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.

Wasser für Injektionszwecke (WFI) Leistungsdaten

Produktion: 500 L/h

Lagertank: 5.000 L

Entnahmemenge: max. 7.000 L/h

Spezifikation (EP/USP)

TOC Online: ≤ 500 ppb

Leitfähigkeit Online: ≤ 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

    Qualitätssicherungssystem

    Bei Qualität gibt es keine Kompromisse.

    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

    Quality control

     

    Multi-compendial physical and chemical tests
    End product testing according to customer requirements
    Microbiological tests
    Elemental impurities analysis of (ICP)
    Stability testing according to ICH guidelines

    Typical areas of application

     

    • Cleaning and rinsing solutions (CIP media)
    • Disinfection of process liquids
    • pH value adjustment
    • Chromatography steps for media and buffer preparation
    • Production of monoclonal antibodies
    • Production of recombinant proteins
    • Vaccines and antibody-drug conjugates
    • Cleaning of stainless steel equipment
    • Protein purification/stabilisation
    • Virus inactivation
    • Diafiltration and purification buffers

    We are a classic contract manufacturing organisation. Manufacturing takes place in a GMP-certified environment. 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.

    Mixing, processing and repackaging of liquid and solid materials, container capacity up to 5,000 litres per batch (stainless steel/PVDF), and manufacture of standard and customer-specific buffers for upstream and downstream applications.

    With our individual packaging concepts, we offer solutions for transport that are both innovative and sustainable.

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