Medico Domus Solid Dosage Forms Plant started operation on 01.12.2012. The plant has been designed to produce Food Supplement solid dosage form products in the form of tablets, caplets, capsules and sachets packed powders. The rated annual capacity of the Plant is approx. 100.000.000 tablets and approx. 6.000.000 capsules (when working in one shift), with the capability of extending the present capacity by 50%, as the spare premises have been set aside in the production area for this purpose.
Upon completion of the construction works, equipment installation and qualification, the HACCP audit was performed by an independent auditing company, whose report proved that the Plant had been constructed and equipped in compliance with requirements of International Codex of Practice – General prrinciples of Food Hygiene CAC/RCP 1-1969, Rev. 4 (2003), as well as Regulation (EG) No 852/2004 on the hygiene of the foodstuffs and Regulation (EG) No 853/2004 laying down specific hygiene rules for food of animal origin.
The Plant has a national GMP certificate, granted upon the audit performed by the Republic of Serbia Ministry of Health.
Policy of quality
All the systems and process equipment have been qualified and validated in accordance with the most stringent Serbian and European law requirements.
The design has provided a concurrent production of different products. The manufacturing conditions have been designed in accordance with the regulatory provisions related to quality, safety and cross contamination prevention, involving primarily the HVAC system, pressure cascade, clean rooms, personnel and material flows and adequate protective gowning.
The manufacturing process is performed on the high-capacity equipment. The production process starts in dispensing area, continuing on granulation and fluid bed lines using Fluid Bed Drier (capacity of 60kg) , tablet presses (capacity 600-700tbl/min) or capsule-filling machines (500cps/min, size “0“.) All process equipment is equipped with the process control via a touch screen. Electronic personnel access control within the Plant prevents risk of unauthorised access to certain areas of the Plant. All material in contact of product is made of SS AISI 316L and other parts not in contact of products is made of SS AISI 304 and sealed to prevent ingress of product to internal mechanisms.
The manufactured tablets, caplets and capsules are packaged into blisters-packs or bottles. Powders are packed into inline there formed sachets.
Blisterpack machine is used for AL/PVC, Al/PVC/PVDC i AL/AL blisters, capacity 100 blisters/min. A high safety level at the packaging stage is ensured by blister inspection cameras, in-line checkweighers and pharmacode.
As regards the cleanliness classes, the Plant is divided into three areas: White (class 100,000; ISO 8;Hepa filters 13), Grey and Black.
The Plant has its own purified water generation, storage and distribution system, of 50 l/h capacity.