Polpharma Pharmaceutical Works - API Manufacturer

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cGMP Pilot Plant   

Cutting edge technologies, FDA approved

 

 

 

Number of Employees:
17
Design temperature ranges:
-20° to +150° C
Capacity:
50L up to 1600L

 

 

Safety & Precautions

HVAC system to optimize the number of air exchanges to maintain both the necessary level of cleanliness (ISO 8 for product isolation area) and the limiting of the risk of explosion. A dedusting system is utilized with local exhaust hoods in order into provide the required level of containment.

 

Compliance with the current GMP guideline.

State-of-the-art techniques
and practices:              
 

Main equipment:

 

  • Two glass-lined vessels of 100L and 250L with reflux condensers
  • One stainless steel vessel of 500L
  • Three glass-lined crystallizers of 100L, 250L and 500L
  • One movable stainless steel reactor of 150L
  • One Nutch filter in stainless steel (600mm in diameter)
  • One centrifuge, vertical axis of 800L
  • One tray dryer with 10 trays providing a total surface of 14 sqm
  • One granulator (flake crusher) with screen mesh ranging from 0.1 mm to 1.00 mm
  • One micronizer with capacity ranging from 0.5 kg/h to 5.0 kg/h
  • Two syl-oil cooling/heating skids with temperature control in the range of ±1°C

 

Latest news

CEP for Baclofen available

Monday, 02-01-2012
Polpharma has been granted Certificate of Suitability (CEP) by the European Directorate for the Quality of...

Polpharma – the most innovative company in Poland

Friday, 20-05-2011
Polpharma ranked first as the most innovative company in Poland, in a research study run by the Institute...

Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex

Friday, 08-10-2010
Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex for the...

Co-operation between Polpharma and RPG Life Sciences

Tuesday, 05-10-2010
RPGLS and Polpharma announced their co-operation in the development and manufacture of Active...
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Realizacja: Ideo