Contract Manufacturing

European Medical Contract Manufacturing B.V. is your contract manufacturer for liquids, suspensions, gels and powders. EMCM has the capability and expertise to produce organic solvents, aqueous solutions and suspensions from small to large scale.

With a fully automatic closed dosing system EMCM can provide a customer specific bulk product. Sterile filtration results in a sterile product for in-line automatic filling.

The production of highly viscous products, like temperature dependent suspensions and gels, is one of the existing expertise. For the manufacture of these groups of products technologies are in place.

Contract Manufacturing for formulation

Formulation

The formulation of liquids, suspensions and gels can be executed under class A/B aseptic condition or in a class C environment before filling in the required primary packaging.

  • 40 active ISO/GMP manufacturing clean rooms
  • A complete range of formulation vessels and mixing devices
  • Qualified production teams

Filling of ampoules, syringes, vials, and pouches

EMCM is equipped with a range of (semi-) automatic filling units for the filling of organic solvents, aqueous solutions, suspensions, gels as well as powders. All filling processes can be performed under aseptic conditions and will be validated by media simulations according GMP and ISO requirements.

Ampoule filling

Two fully automatic filling units for the aseptic filling of organic and volatile solvents and aqueous solutions into ampoules up to 30 ml are in operation.

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This aseptic process is validated by media simulation and executed by a qualified process team. This filling process can be further extended by inline labelling, a fully automated visual inspection machine and the positioning of an ampoule breaker.

Syringe filling

EMCM has a semi-automatic filling process for the filling of highly viscous suspensions and gels, in operation in the range of 1 ml – 5 ml syringes.

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This technology has scope to be expanded for the filling of dual syringes as well as a fully automatic pre-filled syringe (PFS) line.

Vial filling

A fully automatic filling unit for the (aseptic) filling of liquids, suspensions and gels into vials is in operation.

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The line is equipped with stopper/cap closure devices for 13 mm and 20 mm.

Pouch filling

On special customer request we design filling equipment for the filling of custom-made primary packaging.

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A dedicated custom-made filling line is available for the filling of liquids into plastic and aluminum pouches.

Powder mixing and filling

For the mixing of powder components a powder mixer, including a range of sieving devices, is in operation to guarantee a homogenus bulk product.

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EMCM has the possibility to fill powder into vials, pouches and small containers. An example of a product which EMCM manufactures is bone cement powder.

The equipment is operated by qualified operators and controlled by product specific qualification and validation programs.

Tissue engineering

EMCM developed membranes for several applications based on Porcine Pericardium, making use of the proprietary eCOO® Technology.

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eCOO® Technology is a proprietary technique to clean, sterilise and impregnate animal derived tissue, using supercritical carbon dioxide.