Cephalosporins Unit

cephalosporin

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”.

floor

 

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

Catered Area

Total 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

Origin

Capacity

HVAC System
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

 

delma

Major equipment


Name of the Equipment

Origin

Capacity

Capsule Section
Capsule Filling Machine Dr. Pharm, China 72,000 Cap/hr
Tablet Section
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

 

romanco

 

 

 

Dosage forms manufactured:

 

Oral solid: Tablet (Coated & uncoated)
Capsule
Oral liquid: Powder for suspension
Parenteral: Vial

 

Production Capacity


 

Name of Category Unit Yearly Production Capacity
Capsules Pcs 124,800,000
Powder For Suspension Phials 6,240,000
Injection (Vial) Pcs 12,000,000
Tablet Pcs 39,000,000

 

 

Capacity is calculated considering 240 days per year; 2 shifts per day and 8 hours per shifts.

 

Special Features of Cephalosporin Unit

  • Manufacturing & Packing areas are completely segregated with separate entrance & change rooms.
  • Dedicated Lifts for Raw Material & Finished goods handling between Warehouse & Production floors.
  • SCADA system for Purified Water Generation & distribution systems with monitoring facility from central BMS Room.
  • Fire Detection & Alarm system covering complete building with monitoring facility from central BMS Room & Security Guard station
  • Fire Hydrant system covering complete building (both inside and surroundings).
  • Dedicated Air Handling Units (AHU) for Sterile Area, Packing area, Corridors, WIPs, Dispensing area, processing area & manufacturing areas for individual dosage forms.
  • Door interlocking system to all Air Locks in Production Area.
  • Air Shower facility in both Production & QC areas during Exit from concerned areas.
  • Warehouse (about 15,000 sq ft, situated in Ground floor) with followings facilities : (i)  Dedicated receiving and dispatch bay  (ii) Cleaning and sorting area  (iii) Cool room and cold room  (iv) Dedicated area for rejected material/ product (v) Separate material and personnel entry (vi)    Self-contained sampling booth with separate man and material entry (vii)  Reach truck for storing material/ product on multilevel racks (viii) Dedicated lift for moving Raw materials from and finished product to warehouse (ix) Unidirectional flow of materials and products