Process cleanrooms

In an exceptional setting, the EASE industrial platform offers 4,300 m² of premises, including 2,000 m² of fully equipped clean rooms that replicate an environment similar to international standards.

 

What is a clean room?

A clean room is a controlled environment designed to maintain a high level of cleanliness by minimising the presence of particles and microorganisms.

Clean rooms are mainly used in sectors such as biotechnology, pharmaceuticals and microelectronics.

EASE has 3 production lines

Manufacture of sterile liquid forms

In this area, the main stages of preparing injectables are carried out in parallel in separate spaces:

  • Preparation of packaging items: vials, filling needles, stoppers and crimp caps.
  • Product formulation stage
  • Aseptic filling in RABS
aseptic filling machine

In this area, the main stages of preparing injectables are carried out in parallel in separate spaces:

  • Preparation of packaging items: vials, filling needles, stoppers and crimp caps.
  • Product formulation stage
  • Aseptic filling in RABS

 

 

 

Equipment:

  • Compact ROTA fill & finish line with 10R glass bottle washer, depyrogenation oven, aseptic filling, capping and aluminium crimping machine, under RABS with a throughput of 4,000 bottles/hour
  • MMM autoclave sterilisation of filling needles and cap bowls - Loading, basket assembly, injection nozzle verification, recipe monitoring and recording.
  • Utility checks (steam, softened water, clean steam, autoclave cooling, compressed air)
  • Stérigène visual inspection table

Examples of training courses:

  • Visualisation and work under laminar flow (RABS/isolator)
  • First-level maintenance on production equipment
  • Visual inspection stage
  • Aseptic dressing and procedures in grade B
  • Managing a production line for batches of injectables in conditions that comply with standards
  • Preparing equipment
  • Formulating and sterilising products by sterilising filtration
  • Washing and sterilising containers: feeding bottles into the machine, autoclaving cap bowls
  • Aseptic filling under RABS via a container or single-use bags, capping and crimping: feeding bottles, caps and capsules

Manufacture of dry forms

Compressed in the drum of a laminator

Compression

  • Korch Pro xl100 multi-punch compressor, 25 to 40 kg, 2,000 to 29,000 compressions/hour - 8 punches
  • Punch washing by Steelco washing machine (Ref. DS PH Lab)


Capsule filling and quality control
In this area, capsules are filled with powders, pellets and colloidal liquids. USP-EP pharmacopoeia tests are also carried out here on finished products, tablets and powders.

  • DOTT Bonapace capsule filling machine, 4000 capsules/hour
  • Fracture, dissolution, disintegration, hardness and compaction volumeter tests - SOTAX equipment


Coating and blister packaging
After the granule pressing stage, the tablet can be coated and packaged.

  • MINILAB RC DIOSNA coating machine 7kg/coating
  • PENTAPACK BP 540 blister packaging machine

 

Examples of training courses:

  • Launching and monitoring processes
  • Cleaning 
  • Line emptying
  • Product measurement and quality control
  • Assembling/disassembling equipment

Bioproduction

Upstream bioproduction - Fermentation

In this area, bacterial strains are stored at -80°C, thawed and cultured with a scale-up from 200 mL to 200 L.

Equipment:

  • Inoculum in 200 mL flask
  • Inoculum in 2 to 5 L bioreactor
  • Upscaling in 30 to 200 L stainless steel bioreactor
  • Microbiological safety cabinets (MSCs)
  • Incubators
  • Centrifuges

Upstream bioproduction - Single Use

In this area, cell strains are thawed and cultured with a scale-up from 200 mL to 200 L in single-use bioreactors.

Equipment:

  • Microbiological safety cabinet
  • Flask incubators
  • Disposable bag bioreactors from 10 to 200 L

Downstream bioproduction

In this space, cell debris is separated from the liquid phase and proteins are purified.

Equipment:

  • AKTA Ready purification system from GE Healthcare with BPG 100/500, 140/150, Axichrom 70/300 and 200/300 columns

 

Examples of training courses:

  • First step in bioproduction: mastering techniques and contamination control
  • Key stages of production

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