To prevent cross-contamination between products as well as to safeguard the workers’ health and environmental safety is the prime responsibility of the pharmaceutical manufacturer. Therefore, it is mandatory to manufacture cephalosporin products in separate and dedicated self-contained areas with separate air handling facilities. True to its quality slogan Perpetual Quest for Excellence, we have set up a new dedicated state-of-the-art cephalosporin plant to offer world-class healthcare products
1. Ground Floor:
This is the Warehouse Area with floor space of approximately 17,000 square feet and floor height of 27 feet. It consists of Raw Material Store, Finished Goods Store, Cold Room, Cool Room, Sampling area, Reject store and Office etc. This floor is fully under central Air Conditioning (HVAC) system. Clean room class maintained in the full area is “Control class”.
2. Ground Floor Mezzanine:
This floor consists of Canteen, Laundry, AHU room and Consumable store. It has a floor space of 6300 square feet.
3. First Floor:
This is the Production Area with floor space of 17,000 square feet and floor height of 10 feet. This floor is fully under central Air Conditioning (HVAC) system. Following four clean room classes are maintained in this area:
Clean Class A: 283 square feet
Clean Class B: 755 square feet
Clean Class C: 80 square feet
Clean Class D: 10000 square feet
Control Class: 5800 square feet
4. First Floor Mezzanine:
This floor will be used as Technical area for HVAC system. It has a floor space of approximately 4300 square feet and floor height of 11 feet.
5. Second Floor:
This floor is divided into two sections: QC area and Utility area. This floor has a space of 17000 square feet and height of 13 feet.
QC Area consists of approximately 8000 square feet. It is fully under Central Air Conditioning (HVAC) system. Following four clean room classes are maintained in this area:
Clean Class B: 200 square feet
Clean Class C: 100 square feet
Clean Class D: 1600 square feet
Control Class: 6000 square feet
Utility area consists of approximately 9000 square feet. Utility services such as HVAC equipments, Boiler, Air Compressor, Water treatment plant, Electrical Substation, Engineering Work shop and Engineering offices are located in the utility area.
6. Top Floor:
This floor has a space of 4100 square feet for utility services such as Chiller, pumps etc. This area has a height of 13 feet.
Zone wise Area
|Class-A||Injectable Line (Sterilization to Capping): 123 sftHanging LAF : 42 sftMobile LAF : 12 sftDispensing Booth : 50 sftSampling Booth: 52 sft||283 sft|
|Class-B||Inject able Filling Area, Autoclave Unloading Area, Associated Corridor & Change Rooms||755 sft|
|Class-C||Change Rooms before Inject able Area||80 sft|
|Class-D||Manufacturing areas, WIPs, Tools Rooms, Primary Packing Areas, Office Rooms & Corridors of Production Area.||10,000 sft|
|Social Class||Raw Material Store (Warehouse), Finished Goods Store (Warehouse), Bottles Receiving Area, Vial Receiving & De-cartoning area, Primary & Secondary Change Rooms in Production Area, Secondary Packing Area.||5800 sft|
Information on Utilities
Name of the Equipment
|Chiller||Trane, France||155 Ton x 3 nos = 465 Ton|
|AHU||ACSON, Malaysia||26 nos|
|Dehumidifier||DEHUTECH, Sweden||10 nos|
|Water Treatment Plant|
|Purified water generation unit||BOSCH, Germany||1500 L/hr|
|WFI & pure steam generation unit||BOSCH, Germany||WFI: 500 L/hrPS: 200 kg/hr|
|Power generation||Caterpillar, USA||2.2 MW|
|Air Compressor||COMPARE, Germany||7 m3/min @ 10bar|
Name of the Equipment
|Capsule Filling Machine||Dr. Pharm, China||72,000 Cap/hr|
|Tablet Compression Machine||Cadmach, India||111,000 Tab/hr|
|Coating Machine||Gansons, India||30 kg|
|Dry Syrup Section|
|Integrated Powder Filling, Plugging Cap sealing and Sticker Labeling Machine||Brothers, India||150 bottles/min|
|Inject able Section|
|Autoclave||De LAMA, Italy||1000 L|
|Integrated Vial Washing, Sterilization, Filling, Stoppering and Crimping machine||MACOFAR, Italy||12,000 vials/hr|
|Blister Packing Machine (Wider AIII)||Buchon, Korea||50 cycles/min|
|Blister Packing Machine (Wider AIV)||Buchon, Korea||50 cycles/min|
Dosage forms manufactured:
|Oral solid:||Tablet (Coated & uncoated)|
|Oral liquid:||Powder for suspension|
|Name of Category||Unit||Yearly Production Capacity|
|Powder For Suspension||Phials||6,240,000|
Capacity is calculated considering 240 days per year; 2 shifts per day and 8 hours per shifts.