Tablet Department
- Facility includes Granulation, Blending, Compression, Film Coating, Sugar Coating, Enteric Coating, Tablet inspection and Tablets over printing sections.
- Air handling systems conform to the cGMP requirements.
- Temperature and Humidity Maintained as per Product Requirement.
- 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 are Well Documented.
Capsule Department
- 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.
- Separate Quarantine Areas.
- All Sections having GMP compliance machineries.
- Capsulation section having Semi – Automatic & Automatic Filling, Sorting & Polishing Machines.
- All Process & steps are Well Documented
Pellets Department
- It is kind of GMP model Air Conditioner designed to maintain 25°C ± 2°C temperature and desired RH 55 % with 3-micron filtration and over 30 air changes. Supply Filtered Air through 0.3 micron filter.
- 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.
Packaging Section
- 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.
- Primary section having 4 blister pack and strip pack machine.
- 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.
- ALU/ALU Blister Pack Machine/Sachet Packaging Machine
Air Handling Section
- It is kind of GMP model Air Conditioner designed to maintain 25°C ± 2°C temperature and desired RH 55 % with 3-micron filtration and over 30 air changes. Supply Filtered Air through 0.3 micron filter.
- All Core Process Area are provided with Dedicated AHU and Filtration of 20, 10, 3 and 0.3 Micron Terminal HEPA filter.
- Return Air rises with 20µ Filter are provided in Core Area.
- Ancillary Area with 0.3 Micron filter 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.
Warehouse Section (Raw/Packing Material)
- 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 and Out of specification area.
- Locker System for Storage
- SS Sampling and Dispensing Booth with Reverse Laminar Air Flow system where Man Material Movement is separate
- Quarantined Released Finish Goods Store
- Weighing staging areas provided with Reverse Laminar Air Flow (RLAF) and AHU System with Adherence Class 10,000.
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