Contract Manufacturing

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

With a fully automatic closed dosing system, your contract manufacturer 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.

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2000m2 GMP accredited facilities

  • Cleanrooms ranging from class D up to class A (100.000 up to class 100).
  • Facility Monitoring System controlling humidity, temperature, and air pressure cascades.
  • Real-time environmental status displayed on a screen at the entrance of the complex.
  • Separate “airlock in” and “airlock out” for incoming materials, finished goods, and personnel in accordance with the new Annex 1 regulations in the ISO class 6 cleanroom.

Fill and finish of ampoules, syringes, vials, and pouches

Formulation

A complete range of formulation vessels and mixing devices is available for the formulation of liquids, suspensions and gels. The formulation can be executed under class A/B aseptic condition or in a class C environment before filling in the required primary packaging.

EMCM is equipped with a range of (semi-) automatic filling units for the filling of organic solvents, aqueous solutions, suspensions and gels.

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 are available for the aseptic filling of organic and volatile solvents and aqueous solutions into ampoules up to 30 ml.

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

Syringe filling

EMCM has equipment is installed that is suitable for the automatic filling of parenteral drugs, from aqueous solutions to highly viscous gels into vials and syringes.

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This filling line is an open Restricted Access Barrier System (RABS), suitable for filling both aqueous solutions and high viscous gels under vacuum. The equipment can fill vials of various sizes for subsequent aseptically closure. The used technique (filling under vacuum) allows for filling high viscous gels without air bubbles in the barrel. Environmental monitoring in the ISO class 5 area is integrated in the Lighthouse Facility Monitoring System, providing detailed inline particle count during aseptic filling.

Vial filling

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

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This filling line is an open Restricted Access Barrier System (RABS), suitable for filling both aqueous solutions and high viscous gels under vacuum. The equipment can fill vials of various sizes for subsequent aseptically closure. The line is equipped with stopper/cap closure devices. If needed a freeze drying step can be added.

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 homogenous 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 has developed membranes for several applications, based on Porcine Pericardium.

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Such membranes are processed with eCOO® Technology, a proprietary platform to clean, sterilise and impregnate animal derived tissue, using supercritical carbon dioxide (scCO2).