WHO GMP | GLP | ISO 9001:2015
DRY POWDER INJECTIONS MANUFACTURERS

The facility is equipped with AUTOMATIC MACHINES which are GMP compliance for manufacturing of dry powder injections. The direction of manufacturing line is as follows:

• 1. Automatic Vial Washing Machine
• 2. Sterilising Tunnel
• 3. Automatic Filling and Bunging Machinery
• 4. Automatic Sealing and Labelling Machinery

Separate rooms and partitions have been provided in between the various machines so as to avoid any contamination from any one part to the other. The materials Flow and manpower movement has been designed in a single uniflow direction. Separate Storage spaces for raw materials, packing materials and finished goods have been provided and separate quarantine areas have been provided.. The door interlocking system is provided at all the critical places to avoid air contamination. Complete area of walls is made of hard and impervious material. The ceiling has been made of ACP Sheets. The Floor is painted with epoxy resin material. There are separate changing rooms for entry and exit in the sterile area. All the utility services are provided from the service floor provided on the second Floor of the building, therefore avoiding any contamination and interference by the maintenance staff. Manufacturing and Packaging activities are totally segregated from material and people movement point of view.

The facility is GLP certified. The separate chemical testing laboratory and qualitative analysis equipments laboratory is provided to ensure the best quality of our products from beginning of manufacturing process till the goods are dispatched. The departments are equipped with modern qualitative analysis equipments including HPLC, UV karl Fischer etc are provided and proper records for every analysis are maintained.

Warehouse has segregated entry, storage, & exit system for the raw materials and finished products. Each raw material is placed in quarantine are on arrival, checked for quality and released only when approved by QA department, rejected materials are stored separately in locked compartment.

Manufacturing area has been equipped with 90% recirculation air system with terminally placed HEPA filters. The HVAC system is perfectly designed and we have provided 9 number of AHU’s for the separate air locks, washing area, Tunnel area, packing and sealing rooms, Raw material Stores and sampling areas. The air conditioning has been done as per the requirement of the various areas. Proper Dehumidifiers (Bry Air) have been provided for dehumidification of the respective areas. Proper Air Class is maintained as per the requirements of the area. Laminar airflow stations have been provide in blending, filling,sealing and bung drying areas, thus providing class 100 environment.

In-house microbiology laboratory has been provided which ensures that the aseptic environment in the manufacturing area is tested and maintained.