Pharma Polymers offers its customers the option of clinical sample manufacturing in accordance with international GMP standards. Since the German Technical Service Center moved into new laboratories in 2001, an approved GMP facility is available for our customers for the production of clinical samples and stability batches. This lab complies with EU GMP-guidelines and is prepared to fulfill FDA requirements on a short-term basis. International service is facilitated by our global network of application laboratories.

Aside from the production of clinical samples, we also provide analytical testing under GMP conditions in accordance with the European Pharmacopoeia (Ph.Eur.). In summary, our GMP facility guarantees the use of state-of-the-art equipment, validated methods and qualified staff for designing, manufacturing, analytical testing, packaging, labeling, storing and servicing of clinical samples and stability batches.

We invite customers to audit our GMP facility. Further details are also available in our download section (GMP-Brochure).

Equipment:

• Tablett Press: IMA/Kilian E 150plus MX incl. Metal Detector, Online Tablet Tester and Dust Seperator
  Capacity: 5,400 - 67,000 tablets/hour
• Perforated Pan Coater: Glatt GMPC II with 4 Exchangeable Drums
  Capacity: 1.6 - 45 kg
• Rotor Precision Granulator: Alexanderwerk RFG 150 DA
  Capacity: up to 600 kg/hour
• Fluid Bed Coater: Glatt GPCG 3.1
  Capacity: 0.7 - 4 kg
• High Shear Mixer: Diosna P/VAC 10
  Capacity: 0.5 - 10 liter
• Laboratory Blender: Servolift
  Capacity: 5 or 10 liter conical vessel, max. 30 kg
• Melt Extruder: Leistritz Micro 18 GL-40D Pharma
  Capacity: 0.3 - 5 kg/h
• Extruder / Spheronizer: Caleva 20/ Spheronizer 250
  Capacity: Extruder up to 25 kg/h, Spheronizer up to 10 kg/h
• Analytics: Validated in-house analytics and approved competent contract laboratories