TABLETS AND CAPSULES MANUFACTURING
- Facility includes Granulation, Blending, Compression, Film Coating, Sugar Coating, Enteric Coating, Tablet inspection and Tablets over printing section.
- All sections provided with 3 micron filtered air and terminally 0.3 micron (HEPA) filters.
- Temperature and Humidity Maintained as per Product Requirement.
- Each Cubicle provided with separate AHU.
- Well Equipped I.P.Q.C. Lab.
- Quarantine Area for each section.
- All Section having Required Machinery with GMP Compliance Model.
- Well Trained Supervisory Staff and Operators.
- All Process steps Well Documented.
- Facility includes Blending, Capsulation, Inspection and Sorting.
- All section provided with 3 micron filter air and terminally 0.3 micron (HEPA) filter.
- Temperature and humidity monitor & control.
- Well Equipped I.P.Q.C. Lab.
- Quarantine Areas.
- All Sections having GMP compliance machineries.
- Capsulation section having Semi – Automatic & Automatic Filling, Sorting & Polishing Machines.
- All Process steps are Well Documented.
- Facility includes Pulveriser, Sifter, Coating Pan, Tray Dryer and Blender.
- All section provided 3 Micron Filter Air and Terminally 0.3 micron (HEPA) Filter.
- Temperature and Humidity Monitor & Control (HVAC).
- Separate Quarantine Area.
- Entire Section has GMP Compliance Machines.
- All Process & Steps are Well Documented.
- Primary packing section supplied with 3 micron filter air with terminally 0.3 micron (HEPA) filter.
- Operation carried out under well controlled environment.
- Leak testing facility for strips and blisters provided.
- Secondary packing area having air condition for comfort cooling.Conveyer belts provided for carton filling and shipper pack for each primary packing machine.
- Line clearance procedure followed strictly before starting new batch or product.
- Well trained supervisor and operators.
- Primary section having two blister pack and strip pack machine.
AIR HANDLING SECTION
- It is kind of GMP model Air Conditioner designed to maintain 24 0C ± 2 0C temperature and desired RH with 3 micron filtration and over 25 air changes. Supply Air Filtered through 10 and 3 micron filter.
- All Core Process Area are provided with Dedicated AHU and Filtration of 10, 3 and 0.3 Micron Terminal & Hepa filter.
- Return Air rises with 20µ Filter are provided in Core Area.
- Ancillary Area, Warehouses are provided with Controlled Environment with 10 and 3 Micron Filtration.
- Pressure Gradient of 1 to 1 1/2 mm of Water from Room to Room to Passages as the case may be, which is demonstrated on Manometer.
- Air Handling Systems are validated from time to time.
- Equipped to Manage Total Supply Chain. i.e. receipts of RM/PM, Quarantine, Storage and Dispensing.
- Primary Cleaning by Vacuum on Receipt of Material.
- Separate Quarantined, On Test and Released Storage Areas.
- SS Sampling and Dispensing Booth with Reverse Laminar Air Flow system where Man & Material Movement is separate.
- Locker System for Storage.
- Quarantined & Released Finish Goods Store.
- Weighing & staging areas provided.
- Air Compressor from Industry Reputed Manufacturer.
- On Line Air dryer.
- 0.1 Micron filtered Compressed Air.
- 125 KVA DG set in Case of Power Failure to take case of Critical Operation.
- Dedicated Vacuum Pump for Capsule Filling Machines and other Operation.
- For Primary & Secondary Treatment of Effluents.
- Bore Well
- Source of water supply with R.C.C. storage tanks.
- Each section connected with intercom.
Salient features of Quality Control Laboratory.
- Well Equipped with modern state of the art instrument like HPLC, Spectrophotometer, etc. and Chemical Analysis Section.
- All the requisite sections include Analytical, Chemical, Instrumentation and Microbiological for complete In-house Testing.
- Separate Record Room.
- Well Defined Store for Glassware & Chemicals.
- Dedicated Microbiology Section having separate AHU equipped with HEPA filtered (0.3 micron) air.
- Double Air Lock for Microbiology with U.V. in Air Lock & Laminar air flow room.
- Restricted entry and Double Gowning Procedure in Micro testing room.
- Conference Room for Quality Control & Quality Assurance Equipped with Audio Visual presentation.
- Highly Qualified and Experienced Staff.
- Water & AHU system validation.
- Process, Method, Cleaning, Personal and Equipment Validation adhering to GMP standards.
- To design and approve specifications and test methods for Raw material, packaging material, finished product etc.
- Calibration of instrument.
- Need based procedural development.
- Executing validation.
- Training for QC, Production, Packing group supervisors and Workman for Non Specific and Generalized Training for GMP, Personal Hygiene etc.
- Design Validation for Systems, Process and Equipment.
- Conducting Internal and Vendor Audit.
- Attend and Resolve any Complaint from Party, Client or Authority.
- Monitoring CGMP compliance.
- Documentation & Record Keeping.
- MFC, Dossier & S.O.P Preparation.
- Programming Reviewing Stability Studies of Products.
- Upgrading Manufacturing & Q.C. system.