13.07.17

Successful re-certification: audit confirms GMP norms for Minitüb’s extender production facility

With an intensive audit performed by an external GMP (Good Manufacturing Practice) auditor, Minitüb’s extender production facility has recently been re-confirmed to fulfill norms of GMP production.

The 3 day audit included the inspection of the facility itself, controls of processes and cleanliness, documentation and interviews of personnel. Paying tribute to the top condition of our GMP system, the auditor pointed out the competence of our staff as well as the pleasant working atmosphere he met in any department.

Besides the positive overall impression of facilities, offices, workshops and warehouse, the flawless condition of our production facilities and the gapless and impeccable quality management documentation of our production have been decisive factors for the positive evaluation.GMP is “Good Manufacturing Practice” and means that the production methods have to meet strict regulations and guidelines of considerably higher standards as compared to DIN ISO norms. Product quality and safety are the top GMP priorities. Manufacturing procedures must be exactly described and documented at every level of operation. Seamless traceability of all materials and operating processes has to be assured. Quality control as an integral part of GMP production has to be effective, exception free and fully documented.

Minitüb’s extender production facility has been designed with the know-how of GMP experts and it provides automation of the production procedures to a maximum degree. Raw material flow during manufacturing is handled in a completely closed system for maximum safety and quality. The production software has been especially developed for Minitüb to ensure complete control and documentation for weighing and mixing the extender components.

The whole manufacturing site is supplied with dehumidified and HEPA filtered air from a powerful air conditioning system to ensure perfect conditions for manufacturing and staff. 

Diverse production lines for powdered and liquid extender provide automatic packaging in different volumes such as 1, 5, 10, 20, 50 and 100 liter extender for the powdered products. A specially designed robot packages 1-liter bags into boxes fully automatically.

Quality control comprises analysis of all raw material batches and of all batches of ready-made products. Raw materials are exclusively pharmacopoeia grade and sourced from GMP manufacturers only. They have to undergo tests of sperm tolerance of the relevant species in an incubation trial and physical-chemical tests, before they are released for production. QC of produced batches comprises CASA sperm motility analysis, flowcytometric analysis for acrosome and plasma membrane integrity and microscopic evaluation of acrosomes in external testing labs.

Minitüb’s fully automatic production lines, GMP approved facility and procedures and extensive, consistent quality control without any gaps represent the benchmark of highest quality standard for semen extenders in the industry.