CG Pharma Production

Production in the cleanroom, Grades C and D.

 

We offer our customers the standardised or individualised production and mixing of solids and liquids – in accordance with GMP/AMG §13.

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.

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

API & 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 (API) 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

    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

    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

    CG Pharma Production Product Portfolio

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