Ethical manufactures around 50 tablet products. Sophisticated machinery like rapid mixer granulators and fluid bed driers are used to produce the granules of tablets. These granules are then compressed by high-speed tablet compressing machines. Automatic coating machines are then used to coat the tablets by film coat or sugar coat if necessary. These tablets are then blistered by high-speed automatic blistering machines.
For capsule products fully automatic capsule filling machines are used for dosing and filling the capsules.
Online liquid filling and packaging operation are practiced for liquid products.
Ointments and creams are filled and sealed by automatic machines.
Parenterals products are manufactured in the sterile products’ section. All walls & ceilings of the plant are made of Sandwich Panels giving a smooth & easily cleanable surface free of cracks or crevices. The floors are coated with Self-Leveling Epoxy (SLE) to provide a hard impact & chemical resistant surface. All corners between the floors, walls & ceiling are finished with special coving and epoxy to prevent the accumulation of debris & moisture.
A carefully designed arrangement to control and minimize traffic, particularly in and out of the aseptic areas, is incorporated. Access of personnel to the aseptic area is permitted only through a double lock air shower and after removing street clothing, washing hands with disinfectant solution, and putting on sterile gowns, shoes, facemasks, gloves, and other prescribed attire. Positive air pressure inside is maintained so that no particle can enter inside during entrance of personnel.
All equipment and surrounding work area are cleaned thoroughly at the end of each working day so that no contaminating residues from the concluded process may remain. In the next morning before starting production air sample is analyzed for particle count. Production is started only if the result matches the standard.
The Clean Room is maintained by HVAC System, HEPA filter, laminar air flow, UV radiation and other essential aseptic technique. A well controlled Ventilation and Air Conditioning System is applied to protect the clean room from particulate, microbial or gaseous contamination as well as to maintain the required temperature and humidity in the production area.
High Efficiency Particulate Air Filters have been installed in all critical areas, including the filling and sterilization areas, ensuring no micro-organism or particle can enter the production area.
Apart from HEPA filter Laminar Air Flow is used in the filling line as an additional precaution to protect materials from particulate and microbial contamination.
Water Treatment Plant
A modern water treatment plant has been commissioned in the factory for sterile division. Dimineralized water plant consisting of coagulation system, sand bed, multimedia column, active carbon column, water softener, reverse osmosis and ultra filtration has been installed.
The raw materials of sterile products are imported as sterile grade powder, which enters the production area through double lock pass box. The vials and ampoules, after washing with demineralized water are sterilized by Dry Heat Sterilizer at 2000 C for 2 hours. Rubber stopper& flip of seal are sterilized by Autoclave at 1210 C for 30 minutes. Powder for Injections are aseptically filled under Laminar Air Flow. Water for injection is first sterilized by membrane filtration with 0.2 porosity and then it is filled and sealed in ampoules by automatic machine. The ampoules are again sterilized terminally by autoclave. Then the vials and ampoules are kept in quarantine for 14 days and microbiological and chemical tests are carried out during this period.
LAL Test is also performed to ensure that the product is not only microbial free but also free from pyrogens. Sophisticated analytical apparatus like
Fourier Transform Infra Red Spectrophotometer (FTIR)
High Performance Liquid Chromatography (HPLC)
Atomic Absorption Spectrophotometer
Antibiotic Zone Reader,
Colony Counter etc.
are used to perform these tests. Once the batch passes all the QC tests the vials and ampoules are blistered by automatic blister pack machine and packaged in cartons. The blister packing of the vials and ampoules not only increases the aesthetic value of the product but also provides a barrier for the counterfeiters. 3 more levels of barrier are also provided to make the products tamper resistant.
1. Security foil imprinted with product name is sealed beneath the cap of each vial
2. Product name is imprinted on the blister foil of each vial
3. Hologram security seal is pasted at the opening of each box.
And all these are done to ensure that the patients are getting original quality product they are paying for.