Plant

Vardhman Chemtech Limited has two state of art manufacturing facilities located near Chandigarh. Design of both facilties complies with ICH guideline. One plant is dedicated for Biological products( Pencillin based) , second plant is dedicated for NonBiological products. Both facilties are about 6 Miles apart.

Manufacturing facilties at both places include about 70SS and MSGL reactors ranging from 1.0 KL to 12 KLOut this about 10 are MSGL reactors with capacity up to 6.0 KL. Vardhman Chemctech Limited has modern power processing system like Agitated Nutch filters, Vacuum dryers etc. This make system work without human touch. Powder processing areas are provided with AHU systems.

To back up this production facility , Vardhman Chemtech Limited has strong utilities . Cooling and Heating utilities range varies from 180 to -180 deg.C. Apart from these there are dedicated Nitrogen gas plant, Full Generator back up and off course qualified , experienced manpower and well equipped and self sufficient laboratories.

We believe in clean and Green environment . On environment front sufficient number of scrubbers are provided at every stage . Apart from this all liquid waste generated is treated in Water treatment plant and this is recycled back . 

Unit-III

Sterile facility deploys state-of-the-art technologies and automated facilities that ensure the

Highest levels of process integrity and product quality. Our Sterile plant has been laid down as per US-FDA/ EU-GMP guidelines, cGMP standards, fabrication and support systems. The infrastructure meets the world-class standards.

General description: The building of sterile block is having three floors. The ground floor is having the sterile facility and the system of Water for Injection & Pure steam Generation. First floor is having water system consisting of Purified water generation system. AHU’s and ducting are laid on the first floor with other areas like electrical panel room. HVAC is used for conditioning of air and to achieve the required designed parameters in the clean room like in terms of Viable and Non-viable particles, Temperature, Relative Humidity, and Differential pressures.

System is designed in such a way to minimize the ingress of microbiological and particulate matter contamination.

Each process room is supplied with controlled air through HEPA filters. An intact HEPA filter is capable of retaining at least 99.99 percent of particulates greater than 0.3 µm in diameter.

Equipments: All equipments are constructed, designed, and operated from cGMP point of view. Safety while operation of equipment is considered i.e. pressure / compound gauge, temperature indicators, RPM indicators, rupture disc, view glass, vessel lamp, motor cover, insulation, etc.

Equipments cleaning and Maintenance: Reactors, Agitated Nutsche filter & Dryer, are provided with CIP provision. Plate and frame filter is opened completely for cleaning. Filtration train is cleaned in place. All the product contact parts can be opened and cleaned with ease.

Risk Assessment and its prevention: The facility is engaged in manufacturing of sterile Penicillin’s by aseptic processing. It is prime responsibility to ensure the sterility of product and to avoid any cross contamination to the finished product considering the following aspects:

Personnel: Personnel are trained on entry and exit procedures. All personnel belongings are removed before entry into the plant. Medical checkups as per schedule are done to monitor the health of the personnel working inside the plant. Flow of man and material (raw material and packing material) are designed to avoid any cross contamination. Separate garments are designed for entry into different areas i.e. controlled area, aseptic area.

Raw Material and Packing material (RM / PM) : RM / PM in its packing material before entering inside the plant is de-dusted and packing material is removed outside.