AVENTEK PHARMASUTICALS

Our Vision

Product List
They are producing three products

Dry Injection Capsules Dry Syup

As they are producing three things but here we are going to look that how injection is made from raw material to finished goods how they are going to test that injection what are the procedures in different areas and how the injection came into the market after labeling.

Dry Injection
They are used in surgery and major operations basically it is in the powder form then they are mixed with the distilled water turns out into a liquid form so it could be easily circulated in the blood. As Dry injection will be circulated directly in the blood vaines so clean less in the most important part. Keeping the production unit and transportation from the ware houses should be bactria free also the requirement by the Ministry of Health. As keeping cleanless is the major part of all the production process expensive materials, checks, high level quality, certified and standard arctacture of building and skilled staaf is required with high quality assuarance keeping zero chances of errors.

Contents for the Bacteria Free Environment

IPA Solutions ( ISO PROPHYLE ALCOHOL) Centrally Air Condition Units Temperature Controlling Devices

Air Pressure Units Distrialry Unit Special Suites and Shoes

 Air Tight Glass, Doors and Windows Standardized Construction

RAW Material

Injection Completion Process Now we will discuses how raw materials are processed into a finished dry injections
Raw Material entry through secure transfer window

Filling Area

Quality Check

Sealing Area

Labeling

Final Quality Check

Finished injections ware house

Process in Detail

Raw Materials
From the Back side of the factory raw materials which include different form of chemicals are unloaded from the vehicle into a room which are further transferred into the next room where raw materials packing are being cleaned for eg dust particles. Once Raw materials packing are being cleaned they are transferred to the temperature controlled ware house known as raw material ware house. This raw material Ware House is specially designed for the storage of sensitive chemicals under air conditioning units and temperature devices. This ware house also includes the section for the rejection raw material.

Filling Area
Raw materials are further taken into filling areas were chemicals are mixed in the filling machine and filled in vials (bottles). Now we will be going to follow the procedure how raw material are taken into filling rooms and how worker and pharmacist get into filling room. A worker takes the raw material from the warehouse to a particular room where there is a ultra violet window transfer leads to filling area, so worker put the raw material in the transfer window and turn the ultra violet rays on. There are separate ways for the raw material transfer

and the traveling of the worker toward the filling are. Filling area is the most clean area in the whole facility so extreme checks are considered. So after putting the raw material in the transfer window worker goes into a buffer room number 1 where he change the shoes and turn of the clothes and in under garments enters into buffer room 2, where he puts on a special distiled suit sealed in a can and then enters into buffer 3 where he put on special gloves and spray the IPA solution on its hands and shoes and then further enters into a filling area where he has to spray the IPA solution to kill the bacteria and purify the whole filling area. Further worker takes out the raw material from the transfer window and put besides the filling machine and then move on to next room lead by the filling area, in that next room there are 2 plants, one of the plant is distillery plant for those special suits and rubber stoppers and the other plant is the washing unit for injection vials(bottles). So then worker takes out another suit for the pharmacist which will assist him while filling of injections and also take out required vials set it in filling machine for the filling, after that worker take that suit into buffer 4 and then buffer 5 which is then connected back to buffer 1 and then go back to filling area by buffer 2 & 3 after spraying IPA on his whole suit again. Pharmacist get to the filling by following the the same procedures and buffers. After that they are ready to start production for injection filling but first they make just one injection and handle it to quality assurance department from the transfer window for the quality test to make sure that raw materials and injection is OK before starting the whole production. Quality assurance dept further take the sample to lab and conduct the initial raw material lab test for 2 hours. Initial lab test includes: Identification of chemicals according to required standards PH Water Contents Impurity check ASSAY-APLC Once passes called releasing procedure, give green signal to pharmacist to start production. After getting green signal from QA worker simply put the raw chemicals into filling machine while pharmacist check the quantities and set frequency for electronic filling machine and the rest of the work is done by machine, it mixes and fill the vials and attach the rubber stopper on the vials. Filing machine is new technology machine which produce 35 vials in a minute. After filling the vials on process test is also conducted. There is see through glass in front of the machine outside the glass there are quality assurance people who are observing the process and pharmacist is showing them the injection putting them on different weighing and volume check machine. Readings of those machines are observed by the QA people and particles are also checked. Once approved as per to the standard and requirements by the QA and pharmacist, worker takes the vials in a tray to the next room which is a sealing room for those vials. Room in which vials are being sealed above rubber stoppers is also as clean as filling room because still there is a chance of impurities. Sealing machines automatically seals all the vials and through the

wall transfer the vials to the labeling machine in labeling room by the conveying belt through the wall under high air pressure.

Labeling
Once the vials are sealed it is out of risk of impurity, bacteria and dust particles. So labeling room is like a normal room where air pressure, humidity and cooling is not required. Labeling machine is once again top of the art machine which automatically labels all the vials.

Final Quality Check

Once injection is completed a random sample is drawn from the batch. Those samples are taken for the final lab check before it is shipped out. Final Check include: ASSAY HPLC Appearance - Black Particle Check PH Sterility test, it is 14 day shelf check After the final check it is ready to be shipped out as AVENTEK care for the humanity and promise to deliver the relieve not pain.

Recommendation

Distillery Unit should be attached with buffer II:

Distillery unit in which special suites and rubber stoppers are kept they are to far away, distillery unit should be attached to buffer II, where worker and pharmacist changed their suits. This will prevent extra cost of IPA spray and will save lot of time.

Filling room is very big to maintain:

If we look at the diagram above filling room is very big as compare to filling unit. There is so much extra space which is not being utilized but adding to extra cost. If that room could be smaller according to filling unit IPA spray cost could be reduced a lot because they have to spray the whole room a part from that they have to maintain a certain temperature by running extra HVA/C (high velocity air condition) units with extra expensive air filters attached with them.

Filling and sealing machines

There is so much gap in between filling and sealing machines, they are planning to install a convey belt between these two which will cost them 5 lac apprx. Instead of that they can join these two machine together in a sealing room which is smaller as compare to filling room which will execute the cost of filling room.

Labeling
After the sealing of vials, vials are sent for labeling and then final testing. After the final test the batch will be approved or rejected. If it is rejected the whole batch will be wasted. Which means cost of labeling is also wasted. That can be saved if labeling could be done after final testing.

Distilled water along dry injection:

Dry injection which are being produced at AVENTEK produced has to be mixed with distilled water when they are being used at patients. Right now almost 60% of the companies including AVENTEK is not providing distilled water with the dry injection, which will result into lower cost of packaging and distilled water. What could be done is that they can add a distilled water in the pack of injection although it will increase the cost of packaging but it will create a good name in the market and will be recommended by the doctors as well. It is not necessary that they have to organize a plant for distilled water manufacturing they can easily out source