Ophthalmic preparations are the products applicable to the eye. All ophthalmic products are required to be sterilized and free from foreign particles. They may be presented as either single use or multi use products.

Most liquid ophthalmic products are prepared by using Aqueous vehicles. They also contain stabilizer, wetting agents, surfactant and preservatives. HDPE sterilized bottles are used to fill the solution.

Regular air sampling of area is done by air sampler method and plate method for area monitoring. Cleanliness and sterility are of utmost importance in preparing ophthalmic solutions.

Ophthalmic solution is prepared by using distilled water. The vessels used in preparations are thoroughly washed with distilled water. Different types of solutions are prepared as per Master formula. Sterilization is done by autoclaving or filtration method etc. For ophthalmic solutions autoclaving is done before filling. During autoclaving the solution is heated to 120°C, maintaining the pressure 10 lb per sq. inch for 45 minutes. PH of ophthalmic solution should be neutral and maintained between 6 – 8.

After filtration solution is filled in sterilized HDPE bottles using four head vial filling machine under controlled hygienic conditions. The bottles are then sealed. After visual inspection the bottles are delivered for labeling and packing.

Capacity: 30, 000 bottles per shift of 8 hours.

 

 

 

   
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