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Production Assemblies

Customization of Single-Use assemblies with control of quality, environment, deadlines and costs.

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100% made in France

Based on its experience in Single-Use for several years, Pharmasep has decided to relocate part of its production in France for its customers in the pharmaceutical industry, the CMO/CDMO, the biotech start-ups and R&D laboratories

Our new cleanroom allows us to manufacture from standards to simple or complex custom assemblies that you need at any stage of your process.

Depending on your quality requirements we will be able to manufacture both non-sterile and sterile validated assemblies (SAL 10-6).

As an OEM, we will use the components you have qualified and validated, but we are also there to help you choose other alternatives.

Working with us means working with a partner who listens to you and is attentive to your requirements

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Entrusting the design of your assemblies to Pharmasep ensures :

  • Expertise to develop the best solution
  • A high level of quality
  • Full traceability of the manufacturing process
  • A secure production site with access control
  • Multi-sourcing of validated and qualified components
  • A supply chain management
  • An ISO 9001:2015 certified company

Entrusting us with your assemblies means above all having a long-term relationship with an independent OEM whose customer satisfaction is full of sense

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Our competences

From simple to complex, Pharmasep design your own ready to use assemblies for some applications :

  • Transfer
  • Final Filling
  • Sampling
  • Collection
  • Inoculation
  • Filtration
  • Sterilizing Filtration
  • Filling
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Your project step by step

A single point of contact, close collaboration:

  • Defining your needs
  • Components definition
  • Prototype drawing
  • Prototype production
  • Necessary adjustments
  • Final drawing approved
  • Component procurement
  • Assembly with continuous monitoring
  • Double bagging and packaging
  • Gamma irradiation / Sterility
  • Batch record and full traceability
  • Shipping
  • Follow-up

ISO 7 Production Brochure

https://pharmasep.fr/app/uploads/2022/06/Brochure-Cleanroom-ISO-7.pdf

Single Use Solutions Brochure