|
Pharmaceutical Production Department
Pharmaceutical Production Department, with approximately 200 staffs, divided to three sections solid, solution and suspension. This department is producing over than 170 products such as Gastrointestinal medicine, Cardiovascular medicine, Psychiatric medicine, NSAIDS medicine, Antibiotic and Anti-diabetes in different dosage forms including simple tablets, coated tablets, injection, capsule, drop and oral suspension based on Pharmacopoeia standards.
The overall tasks of Pharmaceutical Production Department are as below:
- Producing all Chemi Darou's products based on Time Schedule arranged by planning department.
- Producing all products based on GMP Regulations, Drug CTD and production’s SOP.
- Creating a desirable quality by using modern machines and suitable building and ancillary facilities as well as employing trained human resources appropriate for their duties.
- Training staffs for required topics related to different part of production in order to improving the knowledge of them.
Pharmaceutical solid production unit:
Chemi Darou's pharmaceutical solid production unit has been considered as the most important department since all tablets and capsules are being provided by this unit. The major processes of this department are granulation, tablet compression, tablet coating, capsule filling, blistering and cartoning.
Granulation:
- Wet granulation: granules are produced by modern machine (F.B.G.D and 2 set of F.B.D with Diosna)
- Dry granulation: compressible grades of raw materials are blended in blending room prior to compression step such as Ranitidine HCL tablet.
Tablet compression:
In this step, powders or granules are transformed to tablet by five modern machines (Killian and Fette models).
Film Coating:
Film coating of tablet is done with six Accela Coata machines and two coating pans.
Capsule Filling:
In this process, the capsules are filled by two set of 16 Station MG2 machines.
Packaging process:
Pharmaceutical products are packed by the most modern machines, Blistering and Cartooning, while following all international standards for producing the highest level of quality.
Blistering and Cartooning Machines (Uhlmann B1260 & BEC300) with the latest technology in the world perform the blistering step, packing stage and put all blisters along with catalogue into the boxes with the highest speed and level of standard.
Two others Blistering Machines (UPS1 & UPS4) are being utilized in packaging unit with considerable fast speed and acceptable standards. Moreover, two modern Marchezini Cartooning Machines made in Italy at the end of UPS4 Machine provide a significant modern automated packaging system with high level of quality.
The most specific feature of this department which should be taken into consideration is employing the expert staffs due to packing the finished products and the presence of knowledgeable technicians who support the machines (if problems occur during packing process) and controlling the quality of product at the production line by expert staffs who are working at In-Process Control Unit.
Liquid Production Unit:
Production of injection in ampoule dosage form and oral solution in oral drop dosage form has been produced by liquid Production Unit.
Injection production Unit:
There are six steps due to producing injections: re-weighing, preparation of bulk solution, sterile filtration, ampoule filling, particle control and final packaging respectively.
First and foremost, ingredients and raw materials are delivered from warehouse and transferred to production unit by Passbox. Secondly, ampoules are made by depyrogenated double distilled water approved by Chemi darou's laboratory. After preparation of bulk solution and sterile filtration, the solution is connected to filling devices via storage tanks. Filing operation should be done in aseptic conditions. Afterwards, the ampoules which require being autoclaved should be heated at 121°C in 20 minutes. After that the ampoules are transferred to particle analysis room. Following this, all ampoules should be examined by optic control machine in terms of volume and existence of particles in ampoules. After printing batch data on ampoules by jet printer, they are transferred to middle warehouse for doing physical, chemical, microbial tests until final approval by Chemi Darou's labs. At the end, ampoules are transported to packaging unit.
Oral drops production Unit:
First of all, ingredients and raw materials are transported from warehouse to the preparation of bulk solution room. Preparation of solution should be based on production’s SOP and using deionized water which both are approved by our Q.C labs. After confirming the prepared solution by our labs, it should be passed from special filter. Then the solutions is poured into a storage tank and transported to the filling room. At this stage, controls during production are performed by our laboratory in order to checking the volume content of bottles compared with standard value. Filling phase starts after Chemi Darou's labs confirmation. This is followed by capping the bottles which were filled by above mentioned solution. Then, a label is pasted on the drop and some information such as batch number and exp. Date are printed on the label by jet printer. Finally, the labeled oral drops are put on a conveyor and carried away towards packing desk automatically.
Powder production Unit for preparation of oral suspension:
Oral suspension unit has been founded in 1388 (2009) in Chemi Darou Company, for setting up this production line; we used some of the most advanced Italian equipment made by DOSA Company.
In this unit, the production activity is run in five phases: granule preparation, filling, controlling and packaging (first and secondary packaging).
All of the production processes of these products are in accordance with GMP regulations and proper facilities established for achievement of better quality of main product.
|