Safety and quality

Patient safety

Safe support

ProPrems® safely supports intestinal microbiota. Manufacturing complies to current GMP standards (FDA GMP; 21 CFR Part 111). Single-dose packaging eliminates the risk of contamination and the bacterial strains are stable at room temperature for two years. In addition, the strains have low MIC-values and do not contain any antibiotic-resistance genes.

Before production

  • Disinfection of room
  • Environmental testing for salmonella, listeria, sakazaakii

During production

  • Increased awareness of contamination risk
  • Extensive analyses for contaminants

After production

  • Extensive analyses for contaminantes
  • Environmental testing for salmonella, listeria, sakazaakii

Manufacturing hygiene

Strict hygiene measures

Our partner Chr. Hansen is a world-leading manufacturer of bacterial cultures with production lines authorized for pharmaceutical production. The internal quality standards and hygiene measures are rigorous to achieve the superior manufacturing quality needed for preterm infants.

Manufacturing control

Rigorous quality control

In each key step during manufacturing, ProPrems® is tested against an expanded panel of microbial contaminants.

All quality criteria must be met at every check-point. If not, the batch is discarded and manufacturing is re-started from scratch.

Contact us for more information.

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