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Facilities

Cytotoxic Tablets

This category of doses points for parenteral preparation. In this category, Ampoules, vials, and dental cartridges are manufactured. Ampoules are single-dose containers filled with sterile material vials are multi dose containers filled with sterile material. The process consists of various parts, mainly 1. Area Monitoring: the category of this small volume parenteral requires large attention for area monitoring. Regular air sampling of the area is done by the air sampler method and plate method. In plate, method plates are exposed for 20 to 30 mins in different areas of parental preparation.2. Decartoning and Washing: vials/ampoules are decartens in a decarten room. They are loaded on different sized trays, and then they are subject to the jet washing machine. Each vial or ampoules are washed three times in one loading. The jet machine is fed with de-mineralized water and compressed and air. De-mineralized water is coming from the tanks stored at the top of the building conductivity of DM water is always less than 12mili simenus. This DM is passed through a pre-filter and then through 0.45 micron and is then injected into the jet washing. Compressed air also runs simultaneously along with the DM water. Good quality of compressed is used in the process.

Compressed air is filtered, dried, and then is supplied to the jet washing machine.3. Drying & Sterilization: washed ampoules/vials are then staged in rows and columns in access trays. These trays are then loaded into a Dry Heat Sterilizer. Each Dry Heat Sterilizer has a capacity of 48 trays averaging, approximately 24000 ampoules per process. Each process consists of 3 stages, namely, evaporation, sterilization, and cooling. Evaporation is done at a temperature of 120° C. this leads to the drying of the vials and ampoules. Temperature is further increased to 350° and is then maintained for 45 mins. This helps in attaining sterilization of vials and the ampoules. After these vials and ampoules are cooled with the jet of cooled, filtered air to a temperature 65 to 70°. These dried and sterilized vials are then taken to the filling area from the baffle zone.

Tablets Section

Several categories are presently manufactured under this section, namely tablet generic, hormone, oncology, and beta-lactam. Separate areas are allocated to each category of the product. Each product is manufactured as per the procedure laid down by the Master formula. The Master formula is made by the Quality Assurance department after considering the composition and the stability of the product. Master formula is handed over by Quality Assurance to the manufacturing department for production purposes. Tablets are generally prepared by mixing the dry powder in a mass mixture then adding the binder and allowing it to mix till the formation of lumps. These lumps are then passed through the multi-mill for the formation of granules. Granules are then dried in a stream of filtered air in a machine named Fluid Bed Dryer. These dried granules are then mixed with lubricating material in a ribbon mixture.

These lubricated granules are then compressed to form the tablets. During compression, in-process quality control measures are taken care of like friability, disintegration, hardness, etc. Some of the tablets, if required, are subject to coating. Different types of coating are done on tablets. The coating is selected as per the market trends available for a particular drug. Sugarcoating, film coating and enteric coating are some of the common coatings done on tablets. Generally, sugar coating is done with ingredients like sugar, gelatin, talc, shellac, etc. In film coating, Aqueous and Non-Aqueous coating is available. Aqueous coating water is the main vehicle along with HPMC, color, talc, polyethylene glycol, etc. In Non-Aqueous coating, Methylene Chloride and IPA are the main vehicles, other ingredients remain the same. The enteric coat vehicle used IPA and methylene chloride along with Enteric coating material instead of HPMC.

Capsule Section

This category of dosage involves the use of hard gelatin capsules. The empty shells are purchased from registered vendors. Empty shells are checked for their weight, size, and dimensions. Material is separately prepared, taking care of the size of the empty shell and the bulk density of the material. During this filling operation, care is being taken to check the relative humidity and temperature of the area. During the whole procedure, the relative humidity of the area should not be above 35%. The temperature not above 25° C.Empty shells are subject to the loader, which under the influence of vacuum loads these shells into a tray. These shells are then separated from the cap by a separating tray.

The tray containing the body is then subjected to the auger filling machine. The powder is being filled with the help of auger. The tray is overloaded with the tray containing the caps and is then subjected to the locking device. The capsules are locked with the help of pressurized air. Filled capsules are visually inspected for the damages on the conveyer belt and then are polished with the help of a polishing machine. Polished capsules are taken in a crate in a plastic bag and then sent to the packaging department—capacity: 1440 capsules in one minute 6 lakhs capsules in one shift of 8 hrs.

Liquid Orals

We have vast experience in manufacturing Liquid orals for humans and veterinary use. We manufacture various types of Elixirs, Oral Solutions, Linctuses, Oral drops, Oral suspensions & Oral emulsions.These oral preparations contain antimicrobial preservatives and antioxidants as well as exepients such as dispersing, suspending, emulsifying, stabilizing, flavouring, colouring and sweetening agents. The range of products includes but is not limited to Cough syrups, Tonics, Antibiotics, Iron Polymaltose syrup, Antacids, The detailed list of oral liquid preparations is available on the website for your reference.

Liquid Injection

This category of doses points for parenteral preparation. In this category, Ampoules, vials, and dental cartridges are manufactured. Ampoules are single-dose containers filled with sterile material vials are multi dose containers filled with sterile material. The process consists of various parts, mainly.1. Area Monitoring: the category of this small volume parenteral requires large attention for area monitoring. Regular air sampling of the area is done by the air sampler method and plate method. In plate, method plates are exposed for 20 to 30 mins in different areas of parental preparation. 2. Decartoning and Washing: vials/ampoules are decartens in a decarten room. They are loaded on different sized trays, and then they are subject to the jet washing machine.

Each vial or ampoules are washed three times in one loading. The jet machine is fed with demineralized water and compressed air. De-mineralized water coming from the tanks stored at the top of the building conductivity of DM water is always less than 12mili simenus. This DM is passed through a pre-filter and then through 0.45 micron and is then injected into the jet washing. Compressed air also runs simultaneously along with the DM water. Good quality of compressed is used in the process. Compressed air is filtered, dried, and then is supplied to the jet washing machine.3. Drying & Sterilization: washed ampoules/vials are then staged in rows and columns in access trays.

These trays are then loaded into a Dry Heat Sterilizer. Each Dry Heat Sterilizer has a capacity of 48 trays averaging, approximately 24000 ampoules per process. Each process consists of 3 stages, namely, evaporation, sterilization, and cooling. Evaporation is done at a temperature of 120° C. this leads to the drying of the vials and ampoules. Temperature is further increased to 350° and is then maintained for 45 mins. This helps in attaining sterilization of vials and the ampoules. After these vials and ampoules are cooled with the jet of cooled, filtered air to a temperature 65 to 70°. These dried and sterilized vials are then taken to the filling area from the baffle zone.4. Filling and sealing: vial filling is done with 6 head filling, auto bunging, and sealing. Dried sterilized vials are loaded on a turntable. They are filled with requisite volume; bung is put on than the flip off, and then the vials are sealed. Dried and sterilized Ampoules are loaded into the hopper. They are filled with requisite volume.

These filled ampoules are cut and sealed with the help of a flame.5. Solution preparation: different types of solutions are prepared as per Master formula. Products that are to be autoclaved after filling and sealing don't require any pre-sterilization of the vehicle. E Products which are not to be sterilized after filling and sealing are sterilized before the addition of medicaments. Sterilization includes heating to a temperature of 120° C and maintaining a pressure of 10lb per square inch for 45 mins. The vehicle gets sterilized. The chemical materials and the medicaments are now added. If required, medicaments are also sterilized by using a suitable vehicle as a solvent then passing the solution through a membrane filter. The prepared solution is then filtered and is added to filling vessels aseptically.6. Checking and Labelling: filled vials and ampoules after subject to sterilization process are sent for visual inspection. Automatic machines with self-loading and self discarding are used for checking purposes.

Sterile Powder For Injection

The company has the capacity to manufacture 60,000 bottles of 60 ml per day; the process involves heating, mixing, filtration, filling, capping, sealing, checking, labeling, packing, and then testing before release. The heating part involves the manufacturing of syrup solution, which can contain sugar, sorbitol as per the master formula. The heating process involves reducing the TVC and other bacterias that are present, though, in small companies in de-mineralized water, heated material is then transferred to the mixing vessels. Material is cooled, and medicaments and other ingredients are added as per the product master formula.

The product is then physically checked by the manufacturing chemist for its pH, flavor, and taste. The material is passed to the eight plates filter press with filters loaded between the plates as per the Sop for the product. The filter press, the pump, and the filling vessel are joined to each other in a row. Material from the filling vessel is sucked by pipes of pistons attached to the filling machine. Washed dried bottles are running in front of the filling machine on the conveyor. They are filled, capped, sealed, and checked. Again, these bottles are taken to a turntable where they are labeled with a sticker machine and are packed in a carton.

Further, these bottles are packed in shipper cartons. During this process, the record is maintained on a form, namely PT1, which exhibits the name of all the persons involved during the process. This form is then attached to the manufacturing record and forwarded to the administrative block. During the packing, samples are drawn by the analyst who has been conveyed by the packaging department for the sample withdrawn. The moment the contents are checked as OK as per the claim, goods are then allowed to dispatch.

Dry Powder for Oral Suspension

Powder for oral suspension is formulated if a liquid preparation has a limited shelf- life because of physical or chemical instability. In this case, the active ingredient is mixed with a diluent base, which is mainly dried sucrose. It also contains suspending agents, preservatives, sweetener, color, and flavor. All the materials are first sifted through a sifter and then mixed in Roto cube Mixer. Mixing is done for a specific time for proper mixing. Samples are sent for validation of mixing. The product is also checked for its pH, viscosity, taste, and flavor.

The whole process of mixing and filling is done under controlled conditions of the area. The Relative Humidity should not be more than 35%, and temperature should not be more than 25° C.The powder is filled as per dosage units in glass, PET or HDPE bottles. The glass bottles are cleaned with distilled water and are dried in drier. The PET and HDPE bottles are cleaned with the help of a vacuum. The powder is filled in bottles with the help of an agar machine with a timer setting. Weight variation, Relative Humidity, and Temperature record is maintained after each half an hour. The capping of bottles is done manually and sealed with the sealing machine. After Visual Inspection, the bottles are delivered for labeling and packing; capacity: 50,000 bottles per shift of 8 hrs.

Ointments

Ointments are prepared by mixing the oil phase and water phase. The oil phase includes light liquid paraffin, soft white paraffin, and emulsifying waxes. The oil phase is first heated to 70° C in a steam-jacketed Planetary Mixer. The active ingredient is dissolved separately in previously heated propylene glycol or distilled water and added to the above. The water phase is prepared by heating distilled water to 60°C.

Preservatives and stabilizers are added. The oil phase is mixed with the water phase at 55 to 65°C in a steam-jacketed Planetary Mixer with continuous stirring. The material is then cooled and filled in aluminum tubes according to the dosage form with the tube filling machine's help. The aluminum tubes are pre-printed and are purchased from the registered vendor. Weight variation is done after each half an hour. After visual inspection, the tubes are delivered to the packing department. Capacity: 30, 000 tubes per shift of 8 hrs.

External Preparations

This section includes preparations intended for application to the skin. This includes lotions, topical solutions, and mouthwashes, etc. Lotions are usually liquid suspensions or dispersion intended for external application to the body. They are prepared by triturating the ingredients to a smooth paste and cautiously adding the remaining liquid phase. Colloidal mill is used for this purpose. Topical solutions are liquid preparations containing one or more soluble ingredients usually dissolved in distilled water. Mouthwashes are aqueous solutions, usually in a concentrated form intended for use, after dilution with warm water. External preparations are prepared in the SS vessel attached to the stirrer. Distilled water is used for the preparation. Stabilizers and Preservatives are also added.

After preparation, the final pH is checked. These preparations are then transferred to the filling vessel with the help of a transfer pump after passing through the filter press. The solution is then filled in bottles which may be glass, PET or HDPE. According to the nature of the medicine. Glass bottles used are previously washed with distilled water and dried in the dryer while the PET and HDPE bottles are cleaned with a vacuum. Bottles are filled with the help of a filling machine attached with pistons. The filled bottles are capped manually and sealed with the help of a filling machine. After visual inspection, these bottles are then delivered for labeling and packing. Capacity: 50,000 bottles per shift of 8hrs.

Opthalmic

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 stabilizers, wetting agents, surfactants, and preservatives. HDPE sterilized bottles are used to fill the solution. Regular air sampling of the area is done by the air sampler method and plate method for area monitoring. Cleanliness and sterility are of utmost importance in preparing ophthalmic solutions. The ophthalmic solution is prepared using distilled water.

The vessels used in preparations are thoroughly washed with distilled water. Different types of solutions are prepared as per the 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 the ophthalmic solution should be neutral and maintained between 6 - 8. After filtration solution is filled in sterilized HDPE bottles using four head vial filling machines 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.