We offer our clients high quality formulation development services for the regulated markets in the US and the European Union (region). The facility houses a state-of-the art formulation development laboratory, an analytical laboratory and a cGMP certified pilot plant.
Maintenance area meeting ISO Class 8 requirements for particle size. Area qualified as per cGMP requirements
Assures adequate control over temperature (below 25ºC), air pressurization and number of air changes per hour. Humidity in processing areas can be reduced up to 30% RH.
System design is based on about 90% re-circulation and 10% of fresh air.
Adequate pressure differential ensuring an environment free from cross-contamination & microbial contamination.
BMS software is used to monitor the environmental conditions.
WATER SYSTEM
Municipal supply water is pre-treated and used as feed water for the purified water plant
Millipore Elix-70 RO / EDI Plant with a capacity to produce 70 liters purified water per hour
200L jacketed tank for storage.
Sanitization is done daily by heating to 80ºC, to ensure microbial purity.
User-points (10 nos) in the processing area with zero dead leg valves.
Distribution is through orbital welded closed loop of SS 316 L pipelines
The loop is under continuous circulation by means of constantly operating pumps to prevent bio-film formation.
The system has been qualified as per approved protocols.
Purified water meets EP, USP and IP requirements for conductivity and TOC.
AIR COMPRESSOR
Air compressors from Ingersoll Rand.
These are ‘reciprocating oil‑free air compressors’ with a total capacity of 100 cfm and qualified annually.
Compressed air is distributed through SS 316 pipelines with 24 user-points.
The compressed air complies with ISO 8573:2010 requirements for Oil, Moisture, Dew-point, & Gaseous hydrocarbons.
DIESEL GENERATORS
Complete back-up by means of diesel generators for all equipment, including stability chambers
Capacities 375 kVA and 125 kVA
DG is programmed to automatically start within 30 seconds of power failure
UTILITY
Utility system qualification is designed to ensure that utilities in use conform to health and safety regulations, as well as pharmaceutical manufacturing standards and cGMP guidelines.