Technology

Trepharm is pharmaceutical manufacturer in Kosovo

  • Each premises intended for production, processing, or storage of a pharmaceutical product is suitable in space, construction and positioning in order to facilitate cleaning, maintenance and to avaid the possibility of material mixing and cross contamination.

  • Operations are performed in areas specifically designed and with proper size. Separate areas and control systems have been implemented for processing in order to prevent contamination or mixing during operations flow.

  • Raw material, in process material and personnel entry routes are separated and do not cross with each other.

  • Flooring, walls and ceilings are made from smooth surfaces easy to clean.

  • There is a system for monitoring parameters of the work environment as temperature and humidity, this data is stored in BMS implemente by Kieback&Peter – Germany.

Ajri & Uji

Air

Air cleanliness, volumes, temperature, humidity and pressures are continuously monitored and recorded in all clean room areas as per cGMP requirements. Air cleanliness is class 100.000. All equipment have been designed and produced by “GEA Klimatechnik GmbH &Co. KG” – Austria. Heating is performed using gas and cooling using water through Chillers. All enforced measures exclude the possibility of air cross contamination. At the same time air is ricirculated and cleaned before it is ejected from the system in order to prevent environmental pollution.

Water

Facility has two circulating types of water: sanitary and purified water. Sanitary water circulates only in service areas and is utilized for cleaning outside Clean Room. In the manufacturing areas Higly Purified water is utilized. Includes water, thus the HP Water is used only for cleaning of the manufacturing areas and equipment. The cGMP regulations have been taken in consideration during design and implementation. Water used in the facility complies to Ph. EUR and USP. Production Equipment All equipment used in production are GMP model (all contact parts and other outer surfaces are from stainless steel). Equipment is automated and have programmed in process quality control during production. Equipment have a high safety level for operators.

Clean Rooms

All areas have suitable lighting. Lighting has been designed and installed by “GEA”, and it complies to EU, CE 73/23/EEC directive, amended with directive 93/68/EEC.

Clean Room installed systems comply with EN ISO 14644: Clean Room areas for pharmaceutical industry are made in compliance with GMP.

A complete installation system includes: cover panels, wall panels, doors, pass boxes, windows, ceilings laminar ceilings and change parts for Clean Room.

Floors are constructed with epokal cement, with epoxy final layer, same as in manufacturing areas. Only areas used by administration, archive and other non production areas have floors covered with tiles.

Electrical systems are designed and installed in accordance to existing laws and regulations.

Production

All areas have suitable lighting. Lighting has been designed and installed by “GEA”, and it complies to EU, CE 73/23/EEC directive, amended with directive 93/68/EEC.

Clean Room installed systems comply with EN ISO 14644: Clean Room areas for pharmaceutical industry are made in compliance with GMP.

A complete installation system includes: cover panels, wall panels, doors, pass boxes, windows, ceilings laminar ceilings and change parts for Clean Room.

Floors are constructed with epokal cement, with epoxy final layer, same as in manufacturing areas. Only areas used by administration, archive and other non production areas have floors covered with tiles.

Electrical systems are designed and installed in accordance to existing laws and regulations.

Quality Assurance

Quality assurance is a system of preventing failures which foresees nearly everything regarding safety of the products, quality standards and regulations. Exactly this system, takes measures to prevent defective product to reach advanced stages of distribution chain.

Quality management system in “Trepharm” is a combination of WHO directives, laws and regulations which guide the production of pharmaceutical products. This is not a rigid system, but a system in development and constant improvement, aiming fulfilment of our client needs in regards of safety, potency, quality, purity, uniformity, credibility and stability of the product.

Quality principles are in accordance with internal procedures used in planning, projecting and constructing the facilities, validation processes, analysis methods and systems.

All departments, as maintenance and engineering, production, quality control and quality assurance function in accordance with quality principles, SOP’s. These procedures are built based on GMP and built into internal structure and regulations of Trepharm.

A good system which leaves nothing to occasion insures expected results.

Quality control

Quality control laboratory is separate area adequate for the intention, constructed based on GLP standard. GLP principles have been developed in order to promote quality and validity of the data of analyzes, used to asses quality and safety of pharmaceutical products.

Quality Control Laboratory in “Trepharm” has been ideated as separate unit with sufficient space and assets for it to fully function as a control unit not only for “Trepharm” but aiming to become a referent laboratory for the region.

Laboratory consists of:

  • Chemical laboratory
  • Instrumental Laboratory
  • Microbiology laboratory
  • Stability laboratory

 

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