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

Suurmond is responding to the growing demand
 

The demanding regulations regarding production in the pharmaceutical industry benefit the quality and safety of products. We increasingly see a demand in R&D for equipment that complies with GMP. Suurmond BV 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

There are quite a few requirements to comply with GMP. Both in terms of the materials used, the roughness of the surface and the cleanability of the dosing system. Because contamination is undesirable and not even allowed. The ultimate goal of GMP is to always guarantee the same high quality product, without the risk of cross-contamination by residual product in any of the components of the process equipment.

Suurmond and GMP

Because Suurmond offers modular solutions, a lot is possible. In terms of material use, selection of components. Suurmond can go very far with this and is willing to go the extra mile. This is possible thanks to our suppliers of high-end components. Our supplier BUCHI is even leading the way with their cGMP reactors.

cGMP glass reactors

Cleaning is extremely important in the pharmaceutical industry. Relevant parts of the BÜCHI cGMP reactors are

BÜCHI cGMP midiPilot glass reactor system
for the clean room

therefore made of stainless steel. The frame is made of welded, polished square stainless steel tubes. The valves also have polished valve bodies and stainless steel handles. The patented büchiflex glass connections are also made of polished stainless steel and have a minimal thread section.
The cover plate is made of Hastelloy C22 with welded Tri-clamp adapter (also available in other materials).

For the clean room, the stirring motor is equipped without external ventilation to prevent turbulence in the clean room. This is also available as an ATEX version.

Switzerland is an important player in the pharmaceutical industry. The Swiss BÜCHI can therefore be called a pioneer in this field. They always respond to new developments on 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. Thanks to our suppliers with the same flexible attitude, Suurmond can offer tailor-made solutions. In the case of GMP, for example, consider 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.

suurDOS® dosing system

An additional advantage of the suurDOS® is that an accurate and pulsation-free flow from 1µl per hour is possible, regardless of the differential pressure and volume flow! This saves you valuable APIs! An economical and safe solution, also for your process!

Validation

GMP provides a number of 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. This also immediately complies with CE.

Documentation

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

DEMANDING PROCESSES, SUSTAINABLE SOLUTIONS!