Sance Laboratories Private Limited

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We, Sance Laboratories Private Limited located at Kozhuvanal, Kottayam District, Kerala, India introduces us as manufacturers of Cephalosporin range of anti-biotic formulations in various dosage forms like Dry powder injections, Tablets, Capsules and Dry powder syrups. The Sance Group is having an experience of 2 decades in pharmaceutical manufacturing. Our building is built over a total land area of 1.5 acres, with a built up area of 64000-sq.ft.RCC structure. We have got a plant with all modern facilities with automatic features for operating the machines.

We are herewith furnishing the facilities provided in our factory for each department.

Manufacturing activities:
We are having a production capacity of 17 million tablets, 4 million capsules, and 0.25 million bottles of dry syrup and 1.5 million vials of dry powder injections monthly, considering one shift operation of 8 hours.
The manufacturing facility has the Drug Manufacturing License and approval from the Kerala State Drug Control Authority, we have already cleared WHO audit, and the plant is built as per international standard. We have plans to go for MCC, MHRA, TGA and US FDA audits in near future.
Area:

We are using aseptic filling process in dry powder injectables. Filling area is class 100 (ISO 5) with class 1000 (ISO 6) buffer zone. The containers and closures after washing and sterilization are exposed only in class 100 areas.
Facility for keeping the sterile areas (Sterile filling area, airlocks and microbiology areas) under positive pressure round the clock is given through automated Building Management System provided by M/s Tata Honeywell Automations Limited, Bangalore and Variable Frequency Drives. By this, we can avoid daily fumigation of the area.
Facility for nitrogen flushing before and after filling is also given. Facility for siliconisation of vials as well as bungs is also given.
The entire production area (sterile and non sterile) is having epoxy flooring.
The entire non-sterile process area is class 1 lakh (ISO 8).
All injection machinery are of M/s Pharmalab, Mumbai.
Formulation & Development:
A suitable size (600 sq.ft. Approx) and well-equipped Product Development Department with pilot scale equipments to develop various formulations is provided in the plant. The product development Department is provided with separate area to conduct accelerated stability studies. The stability study area is equipped with humidity-controlled chambers.
Air Handling System:
Air conditioning plant has got a capacity of 100 tones and it is by Voltas.
M/s CRP, Hyderabad has done the HVAC system.
Kathabar system using Lithium Chloride is used for humidity control. Facility to control the RH and temperature inside the sterile filling hood, dispensing hood and sampling hood below 25 % and 20 degree Celsius is also given.
Water System:
Water system is of M/s Ion Exchange, Mumbai. Purified Water prepared by demineralization (cation, anion and mixed bed) followed by UV sterilization and 1 micron filter kept under continuous circulatory loop in ambient temperature is used for washing in non-sterile area. While demineralized water, after ultra filtration kept under circulatory loop at 80 degree Celsius is used for washing in sterile area. We are having an ETP system to treat the waste materials

Quality Control Department:
The in house quality Control Department is equipped with HPLC, FTIR etc. to give analytical support to analyze the Raw materials, Semi Finished Goods, Finished goods and packing materials. In addition, we have tie up with M/s SGS Laboratories Limited, Kochi, for Analytical services for carrying out specialty analysis which are not facilitated in the unit.
Quality Management System:
The company manufactures, stores and distributes products, which are qualitatively safe for human consumption. To uplift the quality systems, the company maintains the following requirements.
? Maintain/upgrade equipments and buil