Sterile manufacturing

Sterile manufacturing

We provide contract manufacturing services to Life Sciences companies throughout the world :

Pharma & Healthcare

Microbiology

Cosmetics

Veterinary

Wish to outsource the end-to-end manufacturing of your sterile liquid products with time and cost effectiveness ?

Pharmaceutical excipients

Culture media

Cosmetic solutions

Medical devices & in vitro diagnostic

An unrivaled technical expertise and industrial infrastructures for the manufacturing and packaging of your sterile liquid products

Raw material
Sourcing and
Control
  • Supplied by the customer or selected by Indicia under supplier management process.
  • Full raw material QC process carried out by Indicia in accordance with customer’s requirements.
Formulation
  • Formulation in accordance with our customer manufacturing instructions.
  • Mixing in  autoprocessor or tanks (heated or non-heated)fitted with disposable liner.
  • In process QC management.
Aseptic Filling
  • Aseptic filling of liquid reagents is carried out on disposable filling lines, under class A laminar flow in a class B environment, by two experienced operators holding the required authorisations.
  • The production environment is re-qualified in accordance with the provisions of the NF EN ISO 14644 standard.
Labelling &
Packaging
  • Verification of product quality by visual inspection.
  • Labelling according to customer specifications in terms of label format, logo, bar code, flash code, etc.
  • Secondary packaging in boxes then on pallets as required.
Quality
Control
  • QC on finished products conducted by in-house laboratory, according to European Pharmacopoeia and/or ISO reference standards.
  • Custom controls on request.
  • Physical, Chemical, Sterility and Performance testing

An experienced team committed to support the development, transfert and manufacturing of your product

Indicia assists its customers in all steps for a successful industrial application:

 

  • Sourcing of raw materials
  • Pilot batches
  • Scale-up and industrialisation
  • Implementation of regulatory Quality Controls
  • Documentation system and recording
  • Risk analysis
  • Stability studies

We put Quality at the core of everything we do

ISO Certifications

NF EN ISO 9001, NF EN ISO 13485.

Good Manufacturing Practices

relating to medicinal products for human use and active substances used as raw materials in medicinal products.

In-house Quality Control capabilities

European Pharmacopoeia, ISO 21149 (cosmetic)

Experienced Staff

indicia’s technicians hold the required authorisations which are regularly renewed by conducting media fill tests.

Full Traceability

Extensive documentation system (procedures, records, instructions, etc.) recorded within individual batch file

« Since 2005, our facilities have undergone more than 100 regulatory and client inspection »