[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 mill) to perform micronizations in strict compliance with the cGMP guidelines (more than 30 mills available). From the first trial with just a few grams right up to tonnes, 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.

[Translate to English:] Mischen und Homogenisierung von Produkten

 

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 grain sizes you specify.

Modern technology allows sieving of even very fine material. In addition, we can offer protective sieving of your products before further processing in our plant.

[Translate to English:] Prozessvalidierung

cGMP-conform micronization means having a valid process. We are pleased to offer this service by means of the validation of 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 which really pays off.

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

[Translate to English:] Produktsterilisation

We perform sterilization (method according to European Pharmacopoeia) to produce active ingredients and excipients free of germs capable of reproduction (sterile). This can be followed by further production steps such as micronization, blending and packing 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 regularly confirmed by the state authorities of Bremen, Germany.

The central key factor behind our business success is product quality. 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 the 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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