Plant Sepcifics
Plant Technical Overview
Warehouse |
| Separate area for Storage of FG, RM and PM |
| Material receiving , checking , verification, dedusting, weighing and labeling |
| Separate area for raw material, foils and packing material |
| Separate entry for raw material stores and packing material stores personnel |
| Temperature and RH control in raw material and foil stores |
| Separate dispensing booths for pm dispensing |
| Washing area provided for cleaning of sampling rods etc |
| Entry guarded by access control |
Plant Technical Overview
Granulation |
| All granulation area have separate MAL and PAL |
| Granulation -1, has a separate MAL & PAL, RMG,FBD,Sifter, multimill, weighing balance |
| Granulation -2, has a seperate MAL & PAL, FBP, Sifter, multimill, weighing balance, vaccum transfer |
| Granulation -3 has a separate MAL&PAL, sucfficient to set up area for 250 kgs FBP drying per lot |
| Total installed capacity per shift based on 4 lot drying per shift is 720 kgs and is expandable upto a total of 1680 kgs, per shift |
Plant Technical Overview
Blending |
| 2 different blending areas having separate MAL and PAL, capable of handling 2 different products at one point of time |
| 500 Kgs and 250 kgs bin blending areas available expandable to 1000 kgs and 500 kgs respectively, per shift |
Compression |
| 5 different compression cubicles, having separate MAL and PAL, capable of handling 5 different products at one point of time |
| Currently 3 machines have been installed 51, 27, 27 station all b/d tooling |
| Compression is expandable to 51 stn b/d tooling, in each 5 cubicles as the size of the cubicles has been built accordingly |
| Total installed capacity of 2.52 million tablets per shift of 8 hours working |
| Separate area for storage and issue of the dies and punches |
Plant Technical Overview
Coating |
| 3 different compression cubicles, having separate MAL and PAL, capable of handling 5 different products at one point of time |
| Currently 3 machines have been installed 51, 27, 27 station all b/d tooling |
| Installed 2 auto coaters of 36 and 48 inches each. 48 inches with attachment of sugar coating |
| Total installed capacity of kgs per shift of 8 hours working |
Capsule Filling |
| Automatic capsule filling machine with a speed of 0.55 million capsules per shift |
| Machine can fill tablet in capsules, pellets in capsules, powder in capsules and can also fill permutations and combinations of pellets/tablets/powder/granules |
| One cubicles , having separate MAL and PAL |
| The machine area has a capacity of establishing an additional capsule filling machine for increasing the output of the same product at one point of time |
Plant Technical Overview
Oral Liquids
Plant Technical Overview
Secondary Packaging |
| Entry controlled by access control |
| 7 packing lines segregated by partitions having kota flooring |
| Auto – cartonator, auto strapping, auto check weigher and inkjet printers for on line printing |
| Strapping and carton coding facility |
Plant Technical Overview
Primary Packaging |
| 7 different cubicles, having separate MAL and PAL, capable of handling 7 different products at one point of time |
| We have already installed following : 8 track strip packing machine 2 Rotovac blister packing machine with pick and place facility and capabilities of attaching the same with the auto cartonator We have planned for additional one high speed blister packing machine and one high speed alu-alu packing machine Still there will a room for extending the same and adding 2 additional machines |
| The total installed capacity as on today is with 3 machines |
| The immediate expandable capacity is with 2 additional machines |
| With total 7 machines in operation the total capacity will be… |
Plant Technical Overview
New Product Development |
| Dedicated formulation development team |
| Designing drugs for improving bioavailability |
| Trial production lab having prototype equipments, enabling 10 times up scaling |
| Trial production lab maintaining 1,00,000 class |
| Trial batches, development history, Lab scale batches + validation and process optimization |
| Stability studies as per ICH guidelines |
| Separate dedicated quality lab for formulation development and stability study |
Plant Technical Overview
Regulatory Cell: Technical Dossiers |
| Dedicated team of professionals from their expert fields in order to ensure quality documentation |
| Team having a sound knowledge for preparation of dossiers as per CTD or ACTD or ECTD |
| Team headed by Pharmacologists and PHDs |
Plant Technical Overview
Quality Assurance |
| Supreme and independent body reporting to management only |
| Strict control over all aspects of quality like engineering, production, quality control and employee induction + training |
| Validations and Qualifications |
| Root c |
| Periodical self inspections |
| Controls vendor approval and development |
| Deviation and change control |
| Customer complaint, CAPA, product recall, if any and verification of CAPA |
| Following guideline of WHO, PICS, MHRA,ICH, 21 CFR part 210 and 211 |
| Control samples and documentation under access control |
| Stability chambers and data controlled by qa |
| Area segregated by separate building for qa, qc and production |
| Stability Conditions are Accelerated (400C/75% RH), Intermediate (300C/65% RH ), Long Term (250C/60% RH) |
Plant Technical Overview
Quality Control & Management System |
| Our team of experienced and professionally trained people ensures the utmost quality as per the norms laid down |
| Fully equipped with instruments for routine testing of raw materials, packing materials and finished goods |
| The QC section consists of separate 2 floors :
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Chemical lab |
| Separate area for chemical analysis and hot zone |
| Self-reliant with Autotitrator, Karl Fischer Appratus, Autotitrator, Analytical Balance, pH meter, conductivity meter, fuming hood, DT apparatus, Melting Range etc. |
Instrumentation Lab |
| FTIR, HPLC (auto), UV-VIS Spectrophotometer, GC-HS, Dissolution Apparatus ,TOC analyzer and Viscometer etc. |
| Area controlled under hot and cold HVAC system |
| In-house set up for Instruments qualification and calibration like HPLC, Dissolution etc. |
| Entry controlled by acess control system |
Packing Material testing lab |
| Bursting Force testing |
| Gsm tester |
| Moisture tester |
Microbiology |
| Consists of Media preparation, MLT, Bio Safety cabinets, Incubation, Media Disposal |
| Air Sampler, Sterile Dress Cabinet, Autoclave, Analytical balance, pH meter, Conductivity meter, Laminar Air Flow, Bio Safety Cabinets and Incubators. |
| Access controlled by access control system and door interlockings as well as pass boxes |
SUPPORT INFRASTRUCTURE
Water System |
| PLC operated Capacity 1500 ltrs per hour, with data logger |
| Pipeline and vessels with electropolishing with RA finish of 0.4 (inside) |
| Orbital welded joints with boroscopy of 80% joints |
| Hydrophobic filters and fike explosion disc for safety |
| Maintaining USP water specifications, completely automated |
Heat Ventilation and Air Conditioning System |
| Plant consisting of 64 Air handling units maintaining temperature and humidity |
| Multi-tier filteration system 10 mircon at return riser, 10 micron at fresh air, then 5 micron, then 3 micron and then 0.3 micron Hepa at the terminal |
| Having a back up of 3 chillers of 150 ton each, of carrier make with complete automation |
| Separate area given for filter cleaning, filter drying and filter storage |
| Hvac system controlled by BMS ( building management system ) |
Effluent Treatment Plant |
| Modular type skid based ETP system |
| TSS < 100 ppm |
| BOD < 30 ppm |
| COD < 250 ppm |
| Oil and grease < 10 ppm |
| Water being used for the gardening and also reused in toilets |