Symbiotec has installation of state-of-the-art environment-care manufacturing facilities with extreme concern on quality of air & water systems.

STERILE AND CLASSIFIED MANUFACTURING AREA

The manufacturing facilities include sterile manufacturing area and classified areas completely air-controlled by modern double-coating air handling units with thermal breaks, in-built velocity, temperature and humidity sensors. The provision for air locks at passage’s and manufacturing blocks ensures top quality air management. Production areas are epoxy coated with smooth finish and adequate lighting and illumination.

The Sterile API Manufacturing area maintaining class 100 to class 100000 consists the following facilities;

1 Lypholiser Room
2 Buffer Room
3 White Room
4 Grey Room
5 Black Room
6 Compounding Room
7 Pre-Sterilization Room
8 Quarantine Area
9 Sterile Finished Product Storage Room
 

The above facility is equipped with equipment such as ;

1 Lypholiser with CIP and SIP features
2 Dry Heat Sterilizers
3 Steam Sterilizers ( Autoclave )

The Sterile Manufacturing Area is maintained with class of air as high as class 100 with employement of laminar flow and terminal Hepa Filters.

The classified area maintaining class 100000 environment consists the following facilities;

1 Crystalliser Room
2 Micronisation Room
3 Dryer Room
4 Quarantine Area
5 Packing Room
6 Finished Product Storage Room
   

The above facility is equipped with equipment such as ;

1 SS Crystalliser
2 Glass Crystalliser
3 Microniser ( Air Jet Mill )
4 Rotary Film Evaporator
5 Double Cone Vacuum Drier
6 Nutsche Filter
 

The processing area for non-sterile API Consists the following:

1 Production Area
2 Drier Rooms
3 Washing Area
4 RM Store with cold room
5 Packaging Material Store
6 Change Room

The above facility is equipped with equipment such as ;

1 Glass Lined Reactors
2 SS Reactors
3 Double cone vacuum Driers
4 Vaccume Tray Driers
5 Centrifuges
AIR MANAGEMENT SYSTEM
 
The environment at all the manufacturing area’s is controlled from well separated “Air Handling Units ( AHUs)”. The Various AHUs are placed at service floor. The Air Handling Units are double layered with controls such as thermal breaks, built in air velocity, temprature and humidity sensors. The AHUs are driven by variable frequency drives for maintaining accurate differential pressure in various production areas. The various acceptance criterias are critically examined and maintained for achieving highest level of supply air quality.
 

WATER MANAGEMENT SYSTEM

A state of the art water management facility is in full operation at Symbiotec. The water system comprises of a combination of reverse osmosis (RO) and electrodeonization (EDI) equipment ensuring process water quality as per USP 28. This bacterial and endotoxin controlled purified water is further circulated in electro-polished SS loop through-out the plant ensuring that there is no possibility of increase in microbial load before its usage in the process. The water system has online conductivity meters, ph meters, flow meter.

In the eventuality of purified water quality false below the acceptable norms, an automatic water drain system comes into action and prevents the supply to the processing areas.

UTILITIES

Symbiotec is well supported with various utilities. The utility block has various chilling plants , brine plants, boilers, cooling towers, generating-sets, Air Compressors, Water Pumps, Water Softening Plant and well designed Electrical Panels. All the utility equipment are well maintained per schedules and are kept in highest service order.
       
© 2005 Symbiotec Pharmalab Ltd.