[Translate to English:] Mischen und Homogenisierung von Produkten

Micronization under cGMP conditions:

At GfM, we use our air jet mills (e.g. opposed and spiral jet mills) and mechanical mills (e.g. plate beater, pin and hammer mills) to perform micronization in strict compliance with the cGMP guidelines (more than 30 mills available). From the first trial with a few grams to tons, all with certified quality.

Aseptic micronization is an important process step in the manufacture of sterile pharmaceuticals which cannot be sterilized in their final container. This is one of our company’s competitive advantages.

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We can produce homogeneous blends according to your specifications both prior to and following the micronisation processes. Modern container blenders mean that even larger quantities are possible at any time.

[Translate to English:] Produktbezogene Siebverfahren

We perform specific sieving processes to fractionate your product into the particle sizes you specify.

Modern technology allows us to sieve very fine material. We can also provide protective sieving of your products prior to further processing in our facility.

[Translate to English:] Prozessvalidierung

cGMP compliant micronization means having a valid process. We are pleased to provide this service by validating the product manufacturing process. Our service, in which all documentation for validation is closely coordinated with the customer and completed with a wealth of expertise, results in a quality standard that really pays off.

Whether it is cleaning, process or measurement validation, we are the right partner for your product.

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We perform sterilization (European Pharmacopoeia method) to produce APIs and excipients that are free of reproducible germs (sterile). This can be followed by further production steps such as micronization, blending and packaging under aseptic conditions.

Order processing

AT GfM
Manufacturing

Monitoring

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Microbiological monitoring of individual production areas includes surface contact tests (squeeze test), measurement of airborne germs as well as control of process air. Our production employees and production facilities are regularly checked by contact tests. In addition, measurements are carried out to determine the air particle count in the chambers and the process air. Trend analysis are performed to ensure long-term compliance with the standard.

 

Temperature, humidity and pressure measurements are generally carried out alongside productions and process validations.

The ambient parameters as well as the differential pressure are constantly under review and monitored.

Safety for products, the environment and employees

Our success is based on the consistent implementation of cGMP guidelines, which are regularly certified by the state authorities of Bremen, Germany.

Product quality is the key to our business success. The main building blocks for this are the continuous implementation of hygiene plans as well as product group specific storage and manufacturing (dedicated equipment) of active ingredients and excipients.

Environmental protection is an important part of GfM’s corporate philosophy.

The prevention of environmental contamination and its consequences plays a major role. Compliance with cGMP guidelines ensures comprehensive protection.

As our service range includes the processing of potent pharmaceutical products, we guarantee a high level of safety for our employees. This is possible, among other things, thanks to the use of functional protective clothing.

Regular in-house training complemented with external advanced training ensure that our safety measures are always up to date.

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WE LOOK FORWARD TO HEARING FROM YOU!

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