cGMP Pharmaceutical Jacketed Glass Reactor 50L CIP Spray Ball Sanitary Grade Vessel

The FPGR-G50 is a 50 litre jacketed glass reactor configured for pharmaceutical production under current good manufacturing practice. Non glass wetted components are machined from 316L stainless steel and electropolished to Ra 0.4 micrometre, gaskets and seals are platinum cured silicone or virgin PTFE with full material certificates, and every connection is a hygienic clamp fitting that can be dismantled for cleaning verification. The vessel is delivered with an installation qualification and operation qualification package, documentation that auditors now expect before a glass reactor is accepted into a validated suite.

A rotating spray ball mounted in the cover wets the entire inner surface of the vessel, the cover and the underside of the baffle at a flow rate of eight litres per minute, which allows a validated clean in place cycle to replace manual entry. The flush bottom PTFE valve has no cavity in which product can hide, and the agitator is a single piece shaft and impeller with no threaded joints, so there is nothing to unscrew during cleaning. All wetted surfaces can be passivated and the glass body is annealed and inspected for internal stress before it leaves the works.

• Clean In Place Spray Ball: a rotating 316L spray ball covers the full wetted surface at 8 L per minute, supporting a validated CIP cycle without vessel entry
• 316L Electropolished Wetted Parts: all non glass product contact components are 316L electropolished to Ra 0.4 micron with 3.1 material certificates
• Cavity Free Flush Outlet: the bottom PTFE valve is flush with the vessel floor, removing the dead volume that fails a rinse water conductivity test
• One Piece Agitator: shaft and impeller are a single component with no threaded or welded joints, eliminating crevices that resist cleaning verification
• Validation Documentation: IQ and OQ protocols, material certificates, surface roughness reports and calibration records are issued as a bound package
• Platinum Cured Seals: FDA and USP Class VI compliant elastomers with full batch traceability for every gasket in the assembly

Typical duty is clinical trial material manufacture, compounding of ophthalmic and injectable vehicles, dissolution of active ingredient into a sterile filtered vehicle, and the crystallisation steps that precede isolation in a small volume parenteral line. Nutraceutical and cosmetic manufacturers operating to ISO 22716 choose the same configuration when a customer audit demands cleaning validation. Where the reactor is installed in an isolator or a grade C suite, the frame is supplied with levelling feet and a grounded bonding point so that static charge cannot accumulate during solvent transfer.

The unit is assembled and pressure tested at our works, the customer is invited to witness the factory acceptance test, and the complete validation package is issued before shipment. Glass components travel in foam lined cartons with an impact recorder on the outer case. A spare gasket and seal set, a calibration certificate for each instrument and a cleaning procedure draft are included. The vessel carries a twelve month warranty against manufacturing defects. Our engineers support site acceptance testing, and we can re-certify instrumentation on request.