The new Hall of Final Operations (HAFO) was put into test operation on 30th July 2014. The aim of the whole project was to build up new plant which will comply with demanding requirements of state authorities as well as customers for many years. Work safety and operators’ protection as well as protection of living environment against potential contamination were other inconsiderable criteria. HAFO is determined for active pharmaceutical ingredients´ final treatment, i.e. milling, micronization, sieving, packaging and adjustation.
Plant construction and its equipment was part of two project co-financed from Structural funds of EU by the Operation program Business and innovation. There were two projects namely NEMOVITOSTI – 5.3 NM02/1178 „Koncovka chemických výrob – obj. č. 34“ and ROZVOJ – 2.2 RV03/1554 „Modernizace a rozšíření kapacit výroby a adjustace léčivých látek“. Granted dotation significantly helped to decrease total investment into construction and technology and thus markedly speed up whole process of construction and installations.
The HAFO (hall of final operations) premises are designed for the physical treatment and adjustment of pharmaceuticals produced at FARMAK, a.s.
The physical treatment includes grinding or micronization of active pharmaceutical ingredients (APIs) to form the particle distribution size required by the customer. Before further processing, the material is sieved to remove the lumps and possible mechanical impurities (protective screening). The equipment is charged with substances by means of the VTS (vacuum transport system) with the line flow of material.
The equipment is assigned for a dustless operation in the closed system. The substance processing is carried out in two stand-alone boxes which meet the parameters for clean premises, class D. Both of the boxes are equipped with the HVAC ventilation system and an excess pressure against the corridor is permanently kept inside.
One of the boxes was designed for work with the HAPI (high potent API). The pre-cleaning process of the equipment is carried out through the automatic CIP (clean in place) system. The final cleaning of the equipment components is performed by means of an industrial continuous washer, which is located in the washing room. The movement of persons and materials is only possible through personnel and material gates. The HAPI part also includes a decontamination hygienic loop.
ALLGAIER screening machines 2 x
Alpine 160 UPZ impact mill
PRO-MILL, Q-MILL micronization set
CONIWITT 150 conical mill
RETSCH GM 300 knife mill (“pulverization” CIBM pulverizer)
HG 2 Pharmix sieve machine
Alpine Pilot grinding set
Box isolators 2 x (for charging and taring)
VTS – vacuum transport system (for charging)
Laminar box (weighing out samples)
HECHT filling heads 3 x (safe discharging)