Does your reactor or dosing system need to comply with GMP?

Suurmond responds to the growing demand

Product quality and safety both benefit from the demanding regulations regarding production in the pharmaceutical industry. In R&D, the demand for GMP compliant equipment is rising. Suurmond and its suppliers have experience with these strict regulations when it comes to reactors and dosing systems. From lab to production scale.

GMP for high quality and safety

Quite a few requirements are set to comply with GMP, both for the materials used and the roughness of the surface as well as the cleanability of the dosing system. This is necessary because contamination is undesirable and not even allowed. The ultimate goal of GMP is to always guarantee the same high-quality product, without risk of cross-contamination by residual product in one of the components of the process equipment.

Suurmond and GMP

A lot is possible in terms of material use and selection of components thanks to Suurmond offering modular solutions. Suurmond can go far and is even willing to go the extra mile, which is made possible thanks to our high-end component suppliers. Our supplier BÜCHI is even at the forefront with their cGMP reactors.

cGMP glass reactors

BÜCHI cGMP glass reactor system for the clean-room

Cleaning is extremely important in the pharmaceutical industry. Relevant parts of the BÜCHI cGMP reactors are therefore made of stainless-steel.
The frame is made of welded, polished square pipes of stainless-steel. The valves also have polished valve bodies and stainless-steel handles. The patented büchiflex glass connections are executed in polished stainless-steel with a minimal threaded portion.
The cover plate is made of Hastelloy C22 with welded Tri-clamp adapter (also available in other materials).

For the clean-room, motors without external ventilation are used to prevent turbulence. An ATEX version is also available.

Switzerland plays a key role in the pharmaceutical industry. The Swiss company BÜCHI can therefore be called a forerunner in this field. They always respond to new developments in time.

Dosing systems

Many dosing systems are used in the pharmaceutical industry. With the suurDOS® dosing systems, Suurmond goes to great lengths to meet the requirements. Suurmond offers tail-made solutions thanks to their suppliers with the same flexible attitude. For example, in the case of GMP, think of a pump and filter with surface roughness of Ra 0.8 μm, both CIP and SIP cleanable! PEEK tubing and special NPT fittings without corners and dead volume.
An additional advantage of the suurDOS® is that an accurate and pulsation-free flow from 1μl per hour is possible, independent of the differential pressure and volume flow! This saves you valuable APIs! An economical and safe solution, also for your process!

Validation

GMP provides quite a few procedures and guidelines to make every part traceable. All batches must be validated. This means that these are recorded with certificates. Only a carefully recorded and controlled production process ensures the quality of a medicine. For laboratories, this means that DIN is used as a guideline. This is a European directive that also immediately complies with CE.

Documentation

Validation is facilitated by all the documentation and certification we provide. Suurmond makes Inspection documentation available for the wet parts. 3.1 certificates and the Declaration of compliance 2.1 (DIN EN 10204:2005) are supplied for the metal products.

suurDOS® dosing system 

DEMANDING PROCESSES, SUSTAINABLE SOLUTIONS!