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The plant is equipped with latest technology stainless steel automatic optimized machines that fulfill the international regulation for production of solid, liquid non sterile and sterile formulations. A computerized building management system (BMS) permits online monitoring and controlling of the differential pressure, humidity and temperature of the manufacturing facility.Sophisticated air conditioning and filtration systems in all production areas prevent the risk of micro-organisms and cross-contamination. All utilities available at Benta undergo the installation, operation and performance qualification prior to use. A continuous maintenance program is mandatory to be applied to keep the systems qualified.
Solid Line Completely segregated from the liquid production area, the solid form manufacturing area includes dedicated equipments. Weighing is done in roomy area to facilitate easy operation it is controlled by a special, air handling unit that controls temperature, humidity and differential pressure, the air passes through a HEPA filter to avoid cross contamination. This weighing room is equipped with proper balances and scales with printers for tracking purposes. Milling, mixing and granulation are done in the granulation area by an Automatic Single Pot Granulator having capability of producing 50 Tons per year. Mixing is achieved by high-speed rotation of chopper blades. Different features are attached to this machine, Vibro Sifter with different mesh size to perform the milling of powder, elevator to facilitate transferring of powder, Cone Mille and paste Kettle to prepare the granulate. It is also equipped with validated clean in place (CIP) controlled by PLC. Tablet compression is done by a fully automated tablet press machine having 27 stations with two outputs, capable of doing a two layer tablet using either normal gravity or forced feeding system. It is equipped with a digital metal detector and a polishing de-duster. This machine is able to capitulate 750,000,000 tablets per year. Coating is done by an electronically controlled machine able to adjust different parameters of heating, suction, spraying, as well as drying. Its high capacity feature can overcome up to the maximum load of the tablet press machine. Different sizes of capsules are filled with a high precision electronically controlled machine able to stack either powder or granules. Capsule feeding is achieved by a sorter elevator; also it is equipped with an empty capsule sorter, polisher and de-duster. In process controls are done through all manufacturing operations. Humidity, tablet hardness, weight, thickness and disintegration all performed by trained personnel in testing area with qualified equipments.
Liquid Line Liquid manufacturing area is totally isolated from the powder area by an airlock corridor. The liquid preparation area comprises three stainless steel tanks 316L, polished. These tanks are equipped with variable speed mixers and special ball spraying system for CIP. Liquid form packaging line has a blow cleaning machine to blow and suck any particulate glass residue that might occur during the transportation of sterile packed bottles. Then bottles from 60 to 250 mL are filled with an accuracy of 0.05% to 0.1% and closed with child proof plastic capping. The total output of the liquid filling machine is about 2400 bottles per hour. Inspection of the bottles is done visually before going through a self adhesive labeling machine. Finally bottles undergo an automatic cartoner machine with a speed up to 7200 cartons per hour that can run different sizes of cartons as well as leaflets. PackagingLine Packaging line consists of Blister line attached to a cartoner. All aluminum foil used for blistering are printed in-house by a flexo graphic machine having a speed of 16 m per minute. Blister line is EPI servo 3020 AL type. It can run all types of thermoforming PVC and aluminum. The machine can operate either by Alyward universal feeder (USA) or by brush box feeding system. In addition, a Pinhole detector HPF (Germany), and a colored non fill camera system HPF (Germany) that can detect missing, chapped or capped tablets and abnormal, colored or black spots are attached to the machine. It is capable to produce up to 120 blisters per minute. The cartoner is of WHK 100 type with an output of 120 cartons per minute where it can pack from one to five blisters in a single carton. It has a GUK leaflet system and an advanced bar code reader for blisters, leaflets and cartons.
Sterile Line Our sterile manufacturing area is also designed according to GMP requirements. The manufacturing process is carried out in clean areas controlled by BMS. Properly gowned personnel and material pass though airlocks to the different working sections in this area. Sterile area is equipped with a multiple distillery unit with a capacity of 9 liters/minute, and a fully automated filling and sealing machine capable of filling different sizes of syringes with an optimized output of 80 syringes per minute. Prefilled syringes are then packed by a dedicated blister packing machine with a capacity of 450 units/minute. | 
