Biocom
RusEng
THE FLEXIBLE MODULAR PHARMACEUTICAL MANUFACTURE CERTIFIED
FOR THE INTERNATIONAL QUALITY STANDARD GMP
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PRODUCTION

Finished products

Contract manufacturing

Technologic stages

Industrial capacity

Infrastructure

Warehouse

Labs



Finished Products

JSC Biocom is the modern enterprise 2000 m2 in area including tableting and encapsulation department.
At present the company specializes in production of solids due with the application of complete technological cycle. The principle of technology’s fast change allows to pass on to another product very quickly, in 24 hours. JSC Biocom can always guarantee drug efficacy and safety provided by the most intensive and accurate tests which are conducted methodically. Their results can permit our current and future customers obtaining an additional confirmation of wise choice they have made.

Production equipment and facilities as of today:

  • Tablets: 270 million per year (two shifts);
  • Capsules: 100 million per year (three shifts);
  • Secondary packages: 12 million per year (three shifts).

Equipment:

  • Granulator
  • V-mixer
  • Rotary pill-press
  • Coating machine
  • Capsule filling machine
  • German close control weighing equipment
  • Automatic line for packaging into blister, cardboard and outer box.

Quality control department includes chemical-analytical, microbiological and in-process labs, equipped by the most modern European, American and Japanese machinery.
 

Contract Manufacturing

Partnership activity is increasing significantly in the pharmaceutical industry. That makes it essential for the parties on both sides of a potential partnership to explore the opportunity quickly and thoroughly, and to communicate well. Interaction induces all the parties involved to rapid, profitable growth, and to satisfaction of mutual interests. JSC Biocom pays great attention to partnership. From our point of view, collaboration and business relationships are key milestones for success. Respectively, all business development and contracting opportunities are rightfully considered. Besides the complex production of pharmaceuticals JSC Biocom fulfills packaging, labeling and quality control of medicines at any stage of production according to the international quality standard GMP.
As of today JSC Biocom performs secondary packaging of medicines “Topamax 25 mg №60” and “Topamax 50 mg №60” under the contract with Janssen Pharmaceutica N.B. (Belgium).
If you feel that you have something to offer Biocom and/or Biocom has something to offer you, please do not hesitate to contact us. Outsourcing gives a real possibility to make your businesses more productive, more cost-effective and more profitable. Our company is open for collaboration with any player on the pharmaceutical market.
 

Technologic Stages




Manufacturing of finished products at JSC Biocom includes various technologic stages: weighting, sieving, fluid bed granulation, mixing in V-mixer, subsequent tableting and encapsulation. During coating a water-soluble cover is used. These processes are controlled throughout all technologic stages; the stage of mixing is one of the basic check points. Subsequent production of a tablet or a capsule is performed only upon completion of chemical analysis of the mass manufactured in mixer. Analysis is applied to every batch of a product. Tablets or capsules which are produced can be packed into PVC/Alu blisters and into packs with a capacity of 1-5 blisters or packed into glass/plastic bottles with inductive sealing afterwards. During the process of packaging in-process control by quality control personnel and checking of testing units’ functioning by packaging department, in-process lab and quality control personnel are performed every hour. All production stages are recorded in accordance with GMP in forms and protocols which are stated by acting system of quality management.
The department for packaging under the contract is located separately from the departments concerning complete production cycle.
 

Industrial Capacity




The volume of finished product is determined from the point of mixing and makes 100 kg at average which is an optimal load of V-mixer.
Productivity of rotary tablet-press on 36 stations varies from 100 to 220 thousand tablets per hour and depends on both tablet diameter and tableting parameters. The present tableting press allows to produce flat-faced and biconvex tablets with diameter from 5 mm to 16 mm.
Average productivity of capsule filling machine is 40 thousand capsules per hour. Capsule filling machine is intended for solid gelatin capsules filling with powder, pellets, micro tablets and even liquids. It is capable of work with capsules of the following sizes: 00, 1, 2, 3, 4, 5, Supro A-B-C-D-E. Working speed of the packaging line equals to 190 blisters per minute. It has a number of testing units including pharmaceutical code reader unit. Taken as a whole with acting procedures of quality system it allows to reduce a potential possibility of packaging materials’ contamination to zero.
 

Infrastructure




JSC Biocom is equipped by the forced suction-and-exhaust ventilation with the system of air conditioning in order to maintain a specified temperature of air. The central conditioner of the system is manufactured by YORK company. Incoming air is brought to clean rooms through the duct system. Air recirculation is not used in the system, it uses only air injection. The inbuilt air drier ROSENBERG is the add-on to the air conditioning system. The air drier is intended for humidity removal from incoming air and for supply the attended rooms with a dry air.
Under the program of environment parameters monitoring acting on the enterprise there is a regular control of air executed in clean rooms. The system of water purification includes the following stages: the stage of preliminary preparation, the first stage of reversed osmose and the second stage of reversed osmose. There are UV irradiators located in water treatment system and purified water circulation system.
Chemical and microbial parameters of water received and spread to the system comply to requirements of ФС 42-2619-97. Purified water sampling is executed in accordance with schedule from different points. At that, every point of sampling is controlled not less than once per month.
Compressed air can be brought by interchangeable oil-free compressors “Atlas Copco” or “CECCATO”. Indexes of supplied compressed air comply to air that circulates in rooms belonging to D class and are regarded as an area for production and storage of nonsterile drugs. Sampling and testing of compressed air against microbial purity is executed according to schedule once a week by quality control department.
 

Warehouse




The warehouse with a total area of 560 m2 is equipped with three-tier shelves storage system scaled to fit 500 pallets. Raw materials, packaging materials and finished product are stored in the warehouse. Every unit is counted and gets different statuses from “Quarantine” upon entrance to warehouse to “Allowed” upon incoming control completion or upon release of allowance for finished products signed by an Authorized person. There’s a separate sampling room of D class purity within the warehouse.
 
 
 





Lab




Quality control department consisting of chemical-analytical, microbial and in-process control is the integral part of Quality management system.
During all production stages beginning with the stage of raw materials input to the stage of product release quality control is executed. Analysis is performed upon physical and chemical, chemical and microbial indexes in equipped labs with the aid of modern hi-tech facilities by highly qualified experts.
Chemical-analytical lab is equipped with such facilities as HPLC, GC manufactured by Agilent company, IR and UV-spectrophotometers, apparatus for combustion and distillation by Kjeldahl method, solubility tester, disintegration tester and other additional supporting equipment which allows performing different analyses.
















Microbial lab is certified and has a license to operate with bacteria belonging to 3rd and 4th classes of patogenicity. Expendable ware and modern materials are used. Seeding is performed under aseptic conditions created by laminar flow in the class II box. Sterility is tested by closed method of membrane filtration using peristaltic pump “Steritest”. In-lab control procedures and nutrient solution validation are applied.

 
Fluconazole 50 mg
54 Chapaevsky Cr., Stavropol, 355016, Russian Federation
tel.: +7-8652-365356, fax: +7-8652-365355
E-mail: biocom@biocom.ru