This category of doses points for parental preparation. In this category Ampoules, vials and dental cartridges are manufactured. Ampoules are single dose container filled with sterile material vials are multidosed container filled with sterile material. The process consists of various parts mainly.

1. Area Monitoring: the category of this small volume parental requires large attention for area monitoring. Regular air sampling of the area is done by 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 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 than through 0.45 micron and is than injected to 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 than is supplied to the jet washing machine.

3. Drying & Sterilization: washed ampoules/vials are than staged in rows and columns in access trays. These trays are than 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 than maintained for 45 mins. This help in attaining sterilization if vials and the ampoules. After this vials and ampoules are cooled with the jet of cooled filtered air to a temperature 65 to 70°. These dried and sterilised vials are than taken to the filling area from the buffle zone.

4. Filling and sealing: vial filling is done with the help of 6 head filling, auto bunging and sealing. Dried sterilized vials are loaded on a turn table they are filled with requisite volume; bung is put on than the flip off and than the vials is sealed.
Dried and sterilized Ampoules are loaded into 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 which are to be autoclaved after filling and sealing don’t require any pre-sterilisation if the vehicle. E Products which are not to be sterilised after filling and sealing are sterilised before the addition of medicaments. Sterilization includes heating to a temperature 120° C and maintaining a pressure of 10lb per square inch for 45 mins. The vehicle gets sterilised. The chemical materials and the medicaments are now added. If required, medicaments are also sterilised by using a suitable vehicle as a solvent than passing the solution through a membrane filter. Prepared solution is than 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 purpose.

 
 
 
 
 
 
 
 

 

   
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