Facilities | Gentry Pharmaceuticals Ltd

Sreepur Facility

The Clean Rooms

The entire Clean Room is constructed with state of art clean room building materials (sandwich panels, doors, double-glazed vision panels, self-leveling epoxy floors etc.). The ventilation system is designed with a centrally controlled HVAC system with a central water chiller. Separate Air Handling Units (AHUs) are employed for separate areas as per the norms of cGMP, with humidity control for the powder & tablet production areas. The Purified Water System is built on a purified water generator, GMP-compliant storage and a distribution loop with hot water sanitization. There is continuous monitoring of the water quality.

The Technical Service Areas

All the equipment and controlling systems (e.g., AHUs, electrical power, compressed air, potable & purified water, process air handling systems, etc.) are centralized in a dedicated technical zone for central maintenance and control. The area has its own dedicated access (completely separate from Clean Room Access) as per cGMP norms.

Quality Control Laboratory

The Modern QC Lab is divided in separate areas for dry instruments, wet instruments, microbiology, documentation, stability test area, retention sample area, offices etc. With all kinds of testing & analytical instruments available, the QC department ensures high production & quality standards of all the products produced.

Core Production Area

The Core Production Facilities are dedicated controlled Clean Room areas as follows:

Tablets: Wet Granulation Facility with a maximum capacity of 80kg per batch caters to the Tablet Press and Blister Packaging Machine. The tablet production has a capacity of about 25 Million Tablets per year based on single shift operation.
Powders: Powder Processing has a dry blending capacity of 100kg per batch. The powders are packed in containers as well as sachets of different sizes with several packaging machinery. Annual capacity is about 40,000 kilograms on single-shift operation.
Liquids: The Liquid Section has a processing & packing capacity of 500 liters per batch and the products are packed in bottles of 100ml to 1 liter Sizes. The facility has a capacity to pack about 250,000 Liters per year on single-shift operation.

In addition to the above, there are areas available in the core production zone for possible capacity upgrades and also for the introduction of new dosage forms.

Secondary Packaging Area

The Secondary Packaging Area is separated from the Core Production Area as per cGMP norms. The finished and packed goods go through a quarantine measure and quality testing before they are placed in the Finished Goods warehouse for releasing to the market.

The Site

Spanning over a highland, measuring about 11,000 square meters, the site was developed on a fresh piece of land as a green field project. Well-planned buildings are constructed on a land area of approximately 2,500 square meters. The full site comprises of the following modules:

Production Building

The Production Building has a plinth area of 800 square meters and houses the Oral Tablet, Liquid and Powder Production, Packaging & Quality Control facilities. The Production Building Layout is designed and constructed as per cGMP with separate access for production, packaging & technical Areas. The Clean Rooms are designed with central HVAC & hygienic piping networks for potable water, purified water loop, drainage, and dedicated collection network for effluents. The entry/exit of personnel & materials are separated and clearly designated.

Warehouse

The total area of the warehouse is about 600 square meters and with a clearing height of 6.5+ meters. The gross storage volume is about 4,000 cubic meters. The entire area is segregated for raw materials, temperature-controlled raw materials, packaging materials, finished goods, rejected goods, dispensing booths, etc. as per the norms of cGMP. Access to the warehouse is controlled via a dedicated personnel entry area.

Sreepur Facility

The Clean Rooms

The Technical Service Areas

Quality Control Laboratory

Core Production Area

Secondary Packaging Area

The Secondary Packaging Area is separated from the Core Production Area as per cGMP norms. The finished and packed goods go through a quarantine measure and quality testing before they are placed in the Finished Goods warehouse for releasing to the market.

The Site

Spanning over a highland, measuring about 11,000 square meters, the site was developed on a fresh piece of land as a green field project. Well-planned buildings are constructed on a land area of approximately 2,500 square meters. The full site comprises of the following modules:

Production Building

Warehouse

Offices

500 square meters of constructed floor space is available on the first floor for office personnel.

Gentry Pharmaceuticals Ltd.

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