BMT cGMP sterilizers
60000000 INR/Unit
Product Details:
- Type Chamber-type, horizontal, rectangular
- Chamber Size 600 x 600 x 1200 mm (other sizes available)
- Chamber Thickness 6 mm AISI 316L
- Outer Size 1250 x 1350 x 1900 mm (customizable)
- Compressed Air 5 - 7 bar, filtered, dry
- Door Type Double Door, automatic sliding
- Design Pressure 2.5 bar to 3.0 bar
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BMT cGMP sterilizers Price And Quantity
- 1 Unit
- 60000000 INR/Unit
- Microprocessor PLC with touch screen HMI
- Chamber and piping in SS 316L, external panels in SS 304
- ISO 17665-1, EN 285, CE Marked
- Audio-visual for all major faults
- Ra<0.5 m, mirror polished
- Self-draining, slope bottom
- Multiple, for external sensors
- Interlocking doors, overpressure protection, emergency shutdown
- FDA-grade silicone, inflatable
- Approx. 30-60 liters/cycle
- 380V, 50/60 Hz, 3 Phase
- GAMP5, cGMP, IQ/OQ/PQ, DQ, FAT/SAT compliant
BMT cGMP sterilizers Product Specifications
- 6 mm AISI 316L
- Stainless Steel AISI 316L, seamless, sanitary
- 1.25 bar to 2.4 bar
- High density mineral wool, 60 mm
- Stainless Steel AISI 316L perforated design
- Digital, compliant with 21 CFR Part 11
- Saturated clean steam, 2-7 bar
- 1250 x 1350 x 1900 mm (customizable)
- 5 - 7 bar, filtered, dry
- 1C at 121C
- Chamber-type, horizontal, rectangular
- 600 x 600 x 1200 mm (other sizes available)
- Fully sanitary, crevice free design
- Stainless Steel AISI 304 with guide wheels
- Up to 60 minutes (adjustable)
- Sanitary pneumatic valves
- Approx. 1500 kg
- 121C to 134C
- Up to 140C
- 8 kW to 15 kW (depending on model)
- 121C/134C
- 105C to 139C
- Rotary (parallel option)
- 2.5 bar to 3.0 bar
- Double Door, automatic sliding
- Microprocessor PLC with touch screen HMI
- Chamber and piping in SS 316L, external panels in SS 304
- ISO 17665-1, EN 285, CE Marked
- Audio-visual for all major faults
- Ra<0.5 m, mirror polished
- Self-draining, slope bottom
- Multiple, for external sensors
- Interlocking doors, overpressure protection, emergency shutdown
- FDA-grade silicone, inflatable
- Approx. 30-60 liters/cycle
- 380V, 50/60 Hz, 3 Phase
- GAMP5, cGMP, IQ/OQ/PQ, DQ, FAT/SAT compliant
BMT cGMP sterilizers Trade Information
- 1
- 8 Week
- All India
Product Description
Combipro Sterilizers are designed for sterilization of almost any product or container. It is equipped with a vacuum pump for effective sterilization of dry goods, a fan system for steam-air-mixture a sterilization process, and water recirculation pipework for a water cascade sterilization process. Combipro sterilizers are ideal for contract manufacturers or process development centers to establish the optimum sterilization process for any given product or container. Combipro sterilizers can also be equipped with the necessary ports and controls to utilize gas such as HO for the sterilization of heat sensitive containers.Precision Sterilization with Compliance
Designed to meet stringent pharmaceutical and biotech standards, the BMT cGMP sterilizer offers meticulous process control and high-level compliance. Its fully digital system records parameters in accordance with 21 CFR Part 11 and is accompanied by comprehensive GAMP5 and cGMP documentation, as well as test protocols such as IQ/OQ/PQ, ensuring simple validation and audit readiness.
High-Efficiency Design and Construction
Built from SS 316L for all wetted and process-contact surfaces and SS 304 for external panels, this sterilizer resists corrosion and maintains hygiene. The chamber features a mirror-polished finish (Ra<0.5 m) and pneumatic sanitary valves, supporting superior heat distribution and drainage. Customizable chamber and external sizes are available to fit diverse facility needs.
Advanced Safety and Usability Features
Operator safety is maximized with interlocking doors, overpressure protection, and emergency shutdown systems. The inclusion of audio-visual alarms for major faults, user-friendly touchscreen controls, and inflatable FDA-grade silicone gaskets ensures reliable operation and minimizes training requirements for staff, optimizing workplace safety and efficiency.
FAQ's of BMT cGMP sterilizers:
Q: How does the BMT cGMP sterilizer ensure uniform heat distribution during sterilization cycles?
A: The sterilizer incorporates a mirror-polished chamber with seamless SS 316L spraying piping, rotary spraying mode, and high-density mineral wool insulation. These features ensure consistent heat distribution with a deviation of just 1C at 121C, fostering efficient and uniform sterilization of the load.Q: What validation and documentation support does this sterilizer provide for regulated industries?
A: It delivers comprehensive documentation including GAMP5 and cGMP compliance, 21 CFR Part 11 digital recording, and qualification protocols such as Design Qualification (DQ), Factory and Site Acceptance Testing (FAT/SAT), and Commissioning/IQ/OQ/PQ. This ensures robust validation and full regulatory audit readiness for pharmaceutical and biotech applications.Q: When should external sensors be used with the sterilizer's multiple validation ports?
A: External sensors are typically deployed during commissioning, qualification, or critical process validations to independently monitor critical process parameters like temperature and pressure, ensuring that cycles meet specific product and regulatory requirements.Q: Where is this sterilizer commonly installed, and what facilities benefit from its features?
A: The BMT cGMP sterilizer is suitable for pharmaceutical manufacturers, biotech labs, cleanroom facilities, hospitals, and research institutes. Its robust safety, compliance, and customizable features make it ideal for environments requiring validated sterilization processes.Q: What are the main safety features integrated in the BMT cGMP sterilizer?
A: Notable safety components include interlocked double doors (automatic sliding), overpressure protection, emergency shutdown, and an audio-visual alarm system covering all major faults. These safeguard both personnel and products during operation.Q: How is the drainage and cleaning process managed in this sterilizer?
A: With a self-draining, slope-bottom chamber design and mirror-polished surface, the sterilizer facilitates efficient drainage and easy residue removal after sterilization cycles, supporting rapid cleaning and reducing risk of contamination.Q: What are the benefits of using FDA-grade silicone inflatable gaskets in the sterilizer's design?
A: FDA-grade silicone inflatable gaskets provide a reliable, sanitary seal that prevents cross-contamination. Their inflatable design ensures tight, consistent chamber closure, enhancing both sterilization efficacy and operator safety.Tell us about your requirement
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GST : 29AAVCS5053K1ZJ
119, Sylvestra Arcade, East End Road, 11th Cross, Malleswaram,Bengaluru - 560003, Karnataka, India
Phone :07313726629
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