We can offer complete plant comprising:

• Designing the sterile mixing / manufacturing vessels as per highest cGMP standards with system requirements suitable to the best of applications.
• Provide custom Automation as per 21 CFR Part 11
• Filtration for the injectables with necessary cartridge filters and sanitary pumps as of been required.
• Custom required vessel agitation from top or Bottom entry magnetic stirrers; necessary sterile seals; sterile sampling points and fitments.
• Providing qualification documents like DQ, IQ & OQ.
• Sterile piping, valves instrumentation for necessary atomization.
• Mobile Auto CIP & SIP Combo Units with complete traceability and printing facility.
• The characteristic of our injectable plants like crevices and dead leg free surfaces with 0.5 µ ra inside EP and outside Matt finish; assembled with complete 100% Darin ability with flush bottom Diaphragm valve suitable for CIP & SIP with food grade Gaskets compliance with FDA 21 CFR Part 177 -2600 with Bottom Entry Magnetic Stirrer System with Sterile Double Mechanical Seal & Vacuum Powder addition to the system & on going process.
• GMP validated magnetic stirrers with required mixing profile with sterile mechanical seal.
• Skidded Systems with integrated piping, valves & Automation with Inbuilt CIP/SIP System.

Unique features at PPPL been exercised are:

• In house team for design; fabrication & welding activities.
• Traceability for each material been documented.
• No dead legs with cGMP practices through out the unit.
• Provision for CIP / SIP devices.
• Zero Dead Leg (ZDV) & flush bottom valve.
• Supported & Documented by DQ/IQ/OQ.