Stunning cGMP and USFDA-compliant process machinery, custom-built autoclaves, liquid/solid formulation lines, and automated high-shear mixing vessels engineered for maximum yield, batch integrity, and validation assurance.
cGMP
BE&C PHARMA SYSTEMS
Terminal sterilization of LVP/SVP ampoules, vials, and pre-filled syringes using pressurized hot water loops to prevent pressure shock.
| MOC | SS316L, mirror electropolished |
| Accuracy | ±0.5°C chamber temperature deviation |
| Compliance | USFDA 21 CFR Part 11, GAMP 5 |
FDA
BE&C PHARMA SYSTEMS
High-vacuum horizontal steam sterilizers built for cleanroom fabrics, stainless steel change parts, glassware, and waste items.
| Chamber Type | Double-door sliding, pneumatic seal |
| Design Codes | EN 285 / ASME Boiler Code |
| Control Panel | SIEMENS HMI Touch PLC |
OSD
BE&C PHARMA SYSTEMS
Advanced wet granulation mixers with high-speed impellers and choppers designed for cohesive drug blends and uniform pelletization.
| Capacity | 25 Litres to 1000 Litres |
| Impeller Speed | Dual variable frequency (VFD) |
| Seal Type | Air purged sanitary shaft seal |
OSD
BE&C PHARMA SYSTEMS
Efficient fluidization drying lines with multi-stage air filtering, humidity monitors, and explosion relief structures.
| Filtration | EU7, EU13 HEPA (99.97% efficiency) |
| Explosion Proof | 2 bar pressure shock resistant design |
| Batch Size | 50 kg to 500 kg capacities |
Liquid
BE&C PHARMA SYSTEMS
Skid-mounted formulation units containing closed sugar melting reactors, filtration panels, holding tanks, and automatic loop control valves.
| Capacity | 500 Litres to 10,000 Litres |
| MOC | SS316L, Internal electro-polished |
| Automation | Fully integrated load-cells with SCADA |
Topical
BE&C PHARMA SYSTEMS
High-shear vacuum homogenizing mixers designed for topical ointments, lotions, pasty emulsions, and sterile cosmetics.
| Agitator | Contra-rotating scraper mixer |
| Speed Range | Homogenizer up to 3000 RPM (VFD) |
| Vacuum | -0.09 Mpa decompression deaeration |
cGMP
BE&C PHARMA SYSTEMS
Automated rubber stopper washing, sterilizing, drying, and sterile path unloading systems for sterile vial sealing.
| Chamber MOC | SS316L, Electro-polished Ra < 0.2 |
| Process | Wash, Sterilize, Fluid Dry, Unload |
| Control | HMIS PLC SCADA audit trail logs |
FDA Loop
BE&C PHARMA SYSTEMS
Double tube sheet heat exchangers, velocity monitors, TOC analysers, and orbital welded piping loops designed to eliminate bio-films.
| Sanitary class | Electropolished Ra < 0.4 microns |
| Welding Type | Automatic Orbital TIG welding |
| Valves | Zero dead-leg diaphragm valves |
Turnkey EPC
BE&C PHARMA SYSTEMS
Full-scale plant layout engineering, HVAC cleanroom construction, process equipment erection, mechanical piping, commissioning and validation support.
| Standard Scope | Layout, HVAC, Piping, Erection |
| Audits Ready | EUGMP, USFDA, WHO compliance |
| Documentation | FAT, SAT, IQ, OQ, DQ logs |
Detailed technical data table for procurement officers, validation managers, and project directors.
| System Category | Target Equipment | Material of Construction | Internal Polish (Ra) | Automation level | Compliance Standard |
|---|---|---|---|---|---|
| Injectables (SVP/LVP) | Superheated Water Spray Sterilizers | SS 316L, 100% radiography | < 0.4 microns (EP) | PLC/SCADA, 21 CFR Part 11 | USFDA, GAMP 5, EN 285 |
| Injectables (SVP/LVP) | Vacuum Steam Autoclaves | SS 316L, solid jacket plate | < 0.5 microns (EP) | SIEMENS HMI Touch PLC | ASME Section VIII, cGMP |
| Oral Solids (OSD) | Rapid Mixer Granulator (RMG) | SS 316L contact, SS 304 outer | < 0.4 microns (EP) | VFD variable Chopper/Impeller | WHO cGMP, dust-proof class |
| Oral Solids (OSD) | Fluid Bed Dryer (FBD) | SS 316L with multi-bag filters | < 0.4 microns (EP) | Differential pressure PLC sensor | 2 bar explosion panel compliance |
| Liquid Orals | Liquid Oral Prep (LOP) plant | SS 316L sanitary vessels skid | < 0.4 microns (EP) | Load-cells integrated automation | CIP / SIP automated protocols |
| Topical Preparations | Vacuum Cream Emulsifier Mixer | SS 316L contact, jacketed | < 0.4 microns (EP) | High-shear mixer variable speed | Pneumatic hydraulic lid lift |
Optimized for procurement heads locating validation-ready local fabrication yards.
All BE&C PHARMA SYSTEMS units undergo comprehensive weld inspection, video-boroscope filming, pickled passivation, and full DQ, IQ, OQ documentation packets delivered with FAT and SAT protocols at your manufacturing site.
