Third Party Manufacturing
Pharmaceutical Manufacturing Activities
Betamax Remedies is manufacturing Solid Oral Dosage form (Viz. Tablets and Hard Gelatine Capsules), Liquid oral dosage form and External applications (Viz. Liquids, Lotions, Ointments & Creams).
Nature of Construction and Finishes
Buildings are constructed with bricks and RCC structure with Kota stone floorings, jointing of flooring is done by epoxy, Inside walls are plastered to smoothness and painted with epoxy paint. Dead ends are taken care off by coving. The ceilings in the manufacturing areas are ferroconcrete plaster to smoothness and appropriate (Calcium Silicate) false ceiling and painted with washable epoxy paint.
- All lighting in the process areas is either recessed or enclosed.
Brief Description of Ventilation System:
There is schematic ventilation systems in the manufacturing areas. Air-conditioning is provided for all the processing area through air conditioners There are different Air Handling Units for manufacturing area and QC. Hepa filters are provided at various duct openings to avoid cross contaminations. Heaters are provided in air handling units to maintain RH (Relative Humidity) and temperature. Condensing units and heaters work in synchronization through censors, when RH increases above limits automatically heaters start working to maintain permissible RH. There are fresh air units for bottle washing and changing rooms.
Manufacturing Areas
Centralized air-conditioning is provided in this area. Air in this area is filtered through series of filters and finally through 0.3 µ filters provided at plenum. Dust extraction system has been provided in compression areas. Temperature is maintained at comfort condition.
Brief Description of Water Systems
Government supply water is first stored in 50,000 litters under ground R.C.C. Storage tank. Water is uplifted on top floor to another tanks and then processed through R.O. System. Purified water is stored in purified water storage tank of S.S. 316 material and then circulated through Purified water loop system of S.S. 316 material into production area. Purified water is maintained above 60°C.There are designated sampling points and samples are taken at Pre – decided intervals. Sanitation of the water system and loops is carried out according to standard operating procedures.
Manual Entry to Production Area
After changing the personal shoes manual entry to primary changing room is through this corri-door.
There are primary changing rooms for all factory employees separately for ladies and gents, where personal dresses and corri-door slipers are changed and then allowed to enter in secondary changing room. Secondary changing rooms are separate for male & female staff where employees change primary changing room slipers and wear mask, gown and caps and enter into first air lock of main production area.
First air lock for main production area is under 0.3 µ filter area. Second air lock of internal corridoor as shown. Third airlock before which leads to enter to subsiquent production area. Every subsiquent entry is governed by megnahelic gages are provided at every entry to maintaiance presure difference.
Packing
Packing is done under Comfort air maintaining the temperature. Strip packing and Blister packing is done under separate AHUs maintaining RH and Temperature, Pressure in the rooms are maintained by megnehelic gages.