Steam Sterilization facility is a very effective decontamination method.
Sterilization is achieved by exposing products to saturated steam at high temperatures (121°C to 134°C).
Product(s) are placed in a device called the autoclave and heated through pressurized steam to kill all microorganisms including spores.
The device’s exposure time to steam would be anywhere between 15 to 30 minutes, depending on the generated heat.
The Steam Sterilization Process is batch-wise and operating by programmable logic controller (PLC).
PURIFIED WATER PLANT
In order to ensure the condition of formulation, the plant equipped with double pass RO Purified Water and its distribution loop.
•The system was designed to ensure the absence of micro-organism growth by continuous circulating. •The final pharmaceutical grade water result is very good and comply with US Pharmacopoeia. •Our actual TOC is 100 – 200 ppb and Conductivity is < 0.7 – 1 µS/cm, these numbers are both measured online. •Hot and ambient Purified water as well as Pure Steam is taken as a standard for cleaning and sanitizing of production facilities.
QC & MICROBIOLOGY LAB
The laboratory facility design is following Good Laboratory Practice (GLP) to avoid possibility of cross contamination between the laboratory and manufacturing areas, and within the laboratory has different areas for chemical, microbiology and packaging laboratories.
The microbiology laboratory facility has designed following food and drug GMP compliance requirement standard. The Analysts have been trained and capable to do test method validation.
The laboratory equipment’s are having good capability and design as well as capacity function according to standard test method of Principals.
In such manner we have equipment’s to carry out the specified test, e.g. Ultra Performance Liquid Chromatography (UPLC), FT-IR Spectrophotometer, UV- Visible Spectrophotometer, KF Titrino, DMS Titrino, Viscometer, ph Meter, Analytical Balance, etc.
POWDER PLANT FACILITY
Powder lines has the capability for mixing, filling and packing.
HACCP has been applied for mixing area system to prevent contamination.
Filling and Packing line equipped with :
•Online check weight
•Top labelling and cap sealing
•Vision scanner system to implement zero defect facility.
LIQUID PLANT FACILITY
Liquid line has capability to produce alcohol, oil and water based formula starting from mixing up to packing, and have flexible automatic filling machines for various shape bottle, tube, as well as pouches and sachet.
Filling and Packing line equipped with automatic capping, on line check weight as well as zero defect facility using vision system.
Purified Water and Pure System are taken as standard for cleaning and sanitizing of liquid facility equipment.