About NBPL Plant :
NBPL factory is situated at Hemayatpur industrial Area, Savar, which is 21 kilometers away from zero point of Dhaka city. It is a five storied building. At present tablet, capsule, oral liquid and pellet for suspension dosage forms under various therapeutic categories like Antibiotics, NSAIDS, Analgesics and Antipyretic, Gastroprokinetic agent, Anti-Histamines and Vitamin and Minerals are being produced in this plant.
Production Area :
Novelta Bestway Pharmaceuticals has sufficient production floor to carry on smooth production. Total production floor area is approximately 5770 square feet in which Tablet manufacturing area is 1900 square feet, Capsule manufacturing area is 182 square feet, PFS manufacturing area is 250 square feet , Liquid manufacturing area is 350 square feet, Total packaging area is 1818 square feet, Over printing area is 70 square feet, Finished goods quarantine is 1200 square feet . Packing zone and utility area is separated from manufacturing rooms. Manufacturing and packaging operations are carried out according to the validated methods through systematically qualified machines with full documentation at all stages of operations. The production site follows the cGMP guidelines for environmental requirement of the manufacturing and packaging.
Major machines /equipments available at NBPL factory :
In NBPL plants followings major equipments are available:
- Capsule Filling Machine
- Double Cone Blender
- Powder Filling Machine
- Liquid Filling Machine
- Tablet Compression Machine
- Rapid Mixer Granulator
- Fluid Bed Dryer
- Tablet Coating Machine
- Blister Packing Machine
QC laboratory equipment:
- FTIR spectrophotometer
- UV Visible Spectrophotometer
- High Pressure Liquid Chromatograph
- Atomic Absorption Spectrophotometer
- Karl Fischer Titrator
- Disintegration Tester
- Dissolution Tester
- Melting point Apparatus
- Muffle furnace
- Moisture analyzer
- Screw type air compressor
- HVAC facility.
- Air conditioners of different type.
Brief description of ventilation system:
Sophisticated HVAC systems is used in Tablet compression areas are for maintaining temperature and moisture level at the desired level. In other areas of this factory , state of art air conditioning system is being used for air handling which collects fresh air from out side and prevents environmental contamination. Compressed air production machine is at far distance from the production building.
Special areas for handling of hazardous materials:
Hazardous materials are handled only in the QC laboratory. Solids are neutralized and collected in separate containers. Extracted gases from the fume hood are neutralized and scrubbed before they are allowed to exit into the external environment
Brief description of purified water system:
Purified water is produced using double Reverse Osmosis system. Raw water is treated with lime, alum and bleaching powder in a reservoir. It is then passed through a pre filter of 10 micron porosity and is collected in multimedia bed where layers of sand and stone are present. From this multimedia bed water is passed through second pre filter having 5 micron porosity and is collected in active charcoal bed tank. From this charcoal bed water and is passed through third pre filter having 5 micron porosity. Then water passes through anionic bed resin and cationic bed resin of two water softener unit. After this water softening mechanism water passes through fourth pre filter having 0.5 micron porosity and is collected in first Reverse Osmosis unit. Here water passes through a semi permeable membrane and is collected in buffer tank. This semi permeable membrane separates anion and cation from water using reverse osmosis mechanism. Water from this buffer tank passes fifth pre filter having 0.5 micron porosity and is collected in second Reverse Osmosis unit. Here water passes through another semi permeable membrane and is collected in final storage tank. From final storage tank water is supplied to delivery line. During this delivery, just after the storage tank, water passes through UV (Ultra Violet) radiation and then through 0.2 micron filter. Thus purified water is obtained.
Preventive maintenance program for equipment:
Major production machinery like Fluid Bed Drier, Tablet press, Coating machine, Blister machine, Encapsulation machine and Auger filling machine etc., are serviced at every 6 months interval. Air compressor, electricity Generator is serviced at the end of every 250 to 300 hours of activity. Minor machinery (locally manufactured) like Conveyor belt, Cap sealing machine, Cone blender, Vacuum deduster, Liquid transfer pump, Liquid filling machine etc are serviced at every 4 months interval. A schedule is prepared at first mentioning the date of servicing and machine name for the next three months and this schedule is distributed to the related department so that they may arrange to off the work at that machine at the schedule date. During this servicing all important parts of the machine is checked and cleaned, re-lubricated and, if necessary, damaged parts are replaced by new spare. After completion of servicing, record is maintained in log book. The whole activity is arranged and monitored under direct supervision of head of Maintenance department.
Equipment calibration and recording system:
All QC equipments are calibrated after each 1 year interval. NBPL invites the local agents of every equipment to calibrate their supplied machine. They issue a calibration certificate for every equipment and a calibration tag is affixed on the visible location of the equipment. Local agents provide qualified people and necessary tool for calibration. A log book is maintained to keep records. Calibration certificates are preserved in separate file.
Brief description of Effluent Treatment Plant (ETP):
Waste water from various sources of operation is collected via drains to ETP. It is then allowed settling down in equalization tank. In the equalization tank mixing is achieved by means of pump by-pass i.e., the excess of pump output. The pump flow is of much higher capacity than required and more than 90% of the flow has to be by-passed (re-circulated back to equalization tank). From equalization tank, waste water is pumped by submersible pump at constant velocity to the flash mixer. Equalization tank contains perforated PVC pipe at the bottom surface, which is connected to the blowers. Air is blown through this pipe for uniform composition of waste water, temperature control and oxidation of the organic compounds. Here air is a contributor for reducing BOD5 and COD.
Treatment procedure is two categories. One is chemical treatment process and other one is biological treatment process. This plant has both of these two processes, which makes the plant more efficient and effective. Here flash mixer is mainly reaction tank under chemical treatment process and biological treatment process includes aeration tank and secondary clarifier.
Water from equalization tank is transferred by submersible pump at a velocity of 1 m3/hr to the flash mixer section. Simultaneously coagulation, flocculation and neutralization mechanism is applied here. Coagulation mechanism includes chemical addition and flocculation process is a mechanical process, accomplished by stirring. For coagulation aluminum sulphate Al2(SO4)3 is added as coagulant and as flocculants lime Ca(OH)2 and anionic polyelectrolyte is added. About 70% suspended solids are precipitated and removed from water mixture in this section. The effluent from the flash mixer is drained out through baffle channel to primary clarifier for settling the flocs. The settled sludge from the Clarifier is diverted to a thick mass by gravity. The overflow from the Clariflocculator is drained out for biological treatment.
Aeration tank contains air diffusers by perforated PVC pipe like equalization tank for air injection. Most of the BOD5 and COD are removed in this section. So this tank is major contributor for controlling BOD5 and COD. A sludge recycle line from secondary clarifier is connected to this tank for sludge recycle because it is activated sludge process. This sludge is necessary for biological treatment. di-ammonium phosphate and Urea is added as a source of nutrient for bacteria.
A pipe is connected to the secondary clarifier to facilitate exit by gravitational force. Water from aeration tank is to the secondary clarifier here and about 30% suspended solids is removed by gravitational force. After a certain time the suspended particles are settled and supernatant liquor transported to filter bed. After getting proper filtration treated water is disposed off to natural drains to natural flowing water bodies.
The thickened sludge from the thickener shall be pumped to Sludge Drying Bed for sand drying into solid cake form or could be discharged to a safe place if any. The dried sludge is transported for disposal. The overflow from the sludge drying bed return back to equalization tank for further treatment.