Pulse vacuum autoclave

Introduction

A pulse vacuum autoclave is a sterilization equipment used for the sterilization of the instruments, the media, and the other items by the steam under the pressure, with the pulse vacuum cycles that remove the air from the chamber, and it is used in the hospitals, the laboratories, the pharmaceutical, and the many other applications. The pulse vacuum autoclave consists of a pressure chamber, a steam generation system, a vacuum system, a control system, and the safety devices, and it operates by the removal of the air from the chamber by the vacuum pulses, the injection of the steam, and the sterilization at the high temperature and the pressure, such as 121 degrees Celsius or 134 degrees Celsius, for the specified time, and the removal of the steam and the drying by the vacuum; the pulse vacuum autoclave provides an effective sterilization with the removal of the air, which improves the steam penetration, and it is used for the sterilization of the wrapped and the porous items, of the surgical instruments, of the laboratory media, of the liquids, and of the many other items, for the assurance of the sterility, and for many other applications, with features such as the programmable cycles, the data logging, and the safety interlocks; the pulse vacuum autoclave is an essential equipment for the sterilization in the medical and the laboratory applications. Pulse vacuum autoclaves are used in the hospitals, in the laboratories, in the pharmaceutical industry, in the research institutions, and for many other applications. With their pulse vacuum sterilization, pulse vacuum autoclaves are essential for the effective sterilization.

Pulse Vacuum Autoclave LBPA-T2020

The capacity of the Pulse Vacuum Autoclave is 257 liters, and its maximum operating temperature is 139℃. It features a vertical sliding single-door structure with a safety interlock dev...

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Pulse Vacuum Autoclave LBPA-T2010

Pulse Vacuum Autoclave has a volume of 250 litres and a maximum working temperature of 139℃. 304 stainless steel sanitary pipes with clamp joints and specifically made pneumatic valves ...

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Standards

IEC 61010-2-040:2020-Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

ISO 17665-1:2006-Sterilization of health-care products-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Complies with the above standards, but is not limited to them.

Features

1. Pulse vacuum autoclave for sterilization of medical, laboratory and industrial instruments using vacuum-assisted steam.

2. High-pressure steam sterilizer with pre-vacuum and post-vacuum cycles for efficient air removal and drying.

3. Suitable for hospitals, dental clinics, laboratories, pharmaceutical, medical device and research facilities.

4. Includes autoclave chamber, vacuum system, steam generator, control panel, trays, and operation manual.

5. Supports sterilization of wrapped/unwrapped instruments, glassware, media, and heat-stable materials at 121/134 degrees C.

FAQ

Q1: What testing scenarios is this autoclave mainly applied to?

A: The pulse vacuum autoclave (pre-vacuum steam sterilizer, also called vacuum autoclave or class B autoclave) is used in hospitals, dental clinics, laboratories, pharmaceutical manufacturing, medical device production, and research facilities to sterilize heat- and moisture-stable items using saturated steam under pressure, with pre-vacuum pulses to remove air from chamber and loads (critical for porous/wrapped/hollow items) and post-vacuum for drying, achieving sterility assurance level (SAL) of 10^-6 (probability of surviving microorganism <1 in 1,000,000). It supports hospital sterile processing (CSSD - central sterile supply department: surgical instruments (wrapped trays, cassettes, hollow instruments (scopes with lumens - vacuum removes air from lumens for steam penetration)), dental instruments (handpieces, burs, forceps - wrapped/unwrapped), laboratory (pipettes, glassware, culture media (liquid - use liquid cycle, not vacuum), biohazard waste (decontamination before disposal), animal cages/bedding), pharmaceutical (equipment, containers, filters, media (terminal sterilization of heat-stable products), gowning materials, sterile manufacturing components), medical device manufacturing (implants, instruments, components - validation per ISO 17665, FDA), and research (cell culture, microbiology lab - media, glassware, pipette tips, biohazard waste). Pulse vacuum (also called fractionated pre-vacuum) works by: (1) Pre-vacuum: pump air out, inject steam, repeat pulses (3-5 pulses) to remove >99% of air (air is the biggest enemy of steam sterilization - air pockets prevent steam contact, especially in wrapped trays, lumens, porous loads); (2) Sterilization exposure: maintain 121 degrees C (15 psi, 15-30 min) or 134 degrees C (30 psi, 3-5 min for wrapped/hollow); (3) Post-vacuum: pump out steam/condensate for rapid drying (critical for wrapped items - moisture causes wet packs (contamination risk)). Compared to gravity displacement autoclaves (no vacuum, relies on steam pushing air out drain - less effective for wrapped/hollow/porous loads), pulse vacuum provides better air removal, faster cycles, and better drying - required for wrapped instrument trays and hollow devices per AAMI/ST79, EN ISO 17665, HTM 2030.

Q2: What standards does the autoclave comply with?

A: The pulse vacuum autoclave follows relevant ISO, AAMI, EN, FDA and GB/T standards including ISO 17665 (sterilization of health care products - moist heat - requirements for development, validation and routine control of sterilization process), ISO 18472 (sterilization equipment - biological and chemical indicators), AAMI ST79 (comprehensive guide to steam sterilization and sterility assurance in health care facilities), AAMI ST55 (sterilization of health care products in health care facilities - contract sterilization), EN 285 (sterilization - steam sterilizers - large sterilizers), EN 13060 (small steam sterilizers - class B, N, S), EN ISO 17664 (processing of health care products - information to be provided by manufacturer for processing), FDA 510(k) (medical device clearance for autoclaves used in healthcare), HTM 2030 (UK - sterilization departments), and GB/T standards for pressure vessels and steam sterilizers. The hardware complies with pressure vessel standards (ASME BPVC, PED (CE), GB 150), IEC 60601-1 (medical electrical safety), IEC 61010 (lab equipment), and is a registered medical device (FDA, CE MDR, NMPA). Routine monitoring: biological indicators (Geobacillus stearothermophilus spores - at least weekly, and every load with implants), chemical indicators (class 4/5/6 integrators/indicators in each package), Bowie-Dick test (daily for pre-vacuum autoclaves - tests air removal; per AAMI ST79, ISO 11140-4). For pharma/medical device, follow GMP (IQ/OQ/PQ, validation per ISO 17665, 21 CFR Part 211). For hospitals, follow accreditation (Joint Commission, AAAHC) and CMS.

Q3: What is the warranty period for the whole autoclave and key components?

A: The whole pulse vacuum autoclave is covered by a 12-24 month warranty (medical devices often 2 years; chamber/pressure vessel may have longer warranty (5-10 years)). The chamber (stainless steel 316L), jacket, vacuum pump, steam generator, valves, controller/software, and housing are covered, while door seal/gasket (wear - replace if leaking; 1-3 years), filters (HEPA, air/water - replace periodically), trays/racks (wear), and water filter (if using distilled/RO water) are consumables/accessories. Damage from improper use, using wrong water quality (tap water causes scaling in chamber/steam generator (mineral deposits damage valves, sensors, chamber; use distilled, deionized, or RO water per manufacturer - critical), overloading (blocking steam circulation, wet packs), door seal damage (closing on instruments, wear), vacuum pump failure (water supply issues, wear), scale/corrosion (poor water quality, not draining), or unauthorized repair is excluded. Extended warranty and service contracts (preventive maintenance, calibration, validation) are standard for medical autoclaves and strongly recommended (sterilization is critical; downtime requires backup). Chamber lasts 10-20 years; vacuum pump 5-10 years; door seal 1-3 years; valves 3-7 years.

Q4: Is this device difficult to operate? Is professional training required?

A: Operation requires trained sterile processing/laboratory personnel (familiar with sterilization principles, loading, monitoring). We provide operation manuals, installation, and training (typically 1-3 days). Proper instrument setup (place autoclave in well-ventilated area (heat, steam exhaust), connect utilities: water (distilled/RO/demineralized - NOT tap water; water quality critical for chamber/steam generator life), drain, power (dedicated circuit, proper grounding; high-power for steam generator), inspect door seal (clean, no damage), check water level (if built-in reservoir), turn on, allow warm-up/standby (reach pressure/temp), daily checks (Bowie-Dick test for pre-vacuum (first cycle of day - tests air removal; if fails, do not use until serviced; per AAMI ST79), chemical indicator in empty chamber or test pack, verify display, door seal), loading (CRITICAL for sterilization success: clean and dry instruments (bioburden must be removed first - cleaning is prerequisite; residual soil protects microbes), disassemble/lumen instruments (hinged instruments open, lumens flushed, disassembled per IFU), wrap items (sterilization wrap (two layers) or containers; allow steam penetration - do not wrap too tightly; place chemical indicator (class 4/5/6) inside each package), load trays (place packages on edge/side (not flat) to allow steam circulation; do not overload (leave space between items, do not block drain/vacuum ports; textile packs on upper shelves, metal on lower (to prevent condensate dripping); hollow items tilted with lumens down/horizontal for air removal/steam penetration/drainage), do not mix incompatible materials (liquids in separate cycle - liquid cycle has no vacuum, slow exhaust to prevent boil-over), select cycle (choose cycle matching load: wrapped instruments (134 degrees C, 3-5 min exposure, pre-vacuum, post-vacuum drying), unwrapped/instruments (134 degrees C, 3 min, fast), porous/textiles (121 or 134, longer), liquids (121 degrees C, 15-30 min, NO vacuum, slow exhaust - vacuum causes boil-over/explosion; use liquid cycle only), glassware/empty (121/134), custom cycles per validation), start cycle, cycle monitoring (autoclave automatically runs: pre-vacuum pulses (3-5), steam injection, ramp to temp, exposure (hold temp/time), exhaust (slow for liquids, fast for dry), post-vacuum drying; monitor cycle parameters (temperature, pressure, time) - display or printout; cycle must reach and maintain specified temp for full exposure time; if cycle fails (temp low, time short, vacuum error) = load NOT sterile - do not use, reprocess), biological indicator (weekly and every implant load: place BI (G. stearothermophilus) in hardest-to-sterilize location (center of largest pack, near drain); incubate after cycle (55-60 degrees C, 24-48 hours); positive control (unexposed BI) must grow; if BI positive = sterilization failure - quarantine load, investigate, service, repeat BI testing (3 consecutive negative before returning to service per AAMI)), post-cycle (allow drying (post-vacuum; packages should be dry - wet packs = contamination risk, do not use; if wet, reprocess), cool down (15-30 min; hot items can burn, and condensation from cold room), use heat-resistant gloves to unload, inspect chemical indicators (must change color per manufacturer; if not changed = sterilization may have failed - reprocess), check package integrity (no tears, no moisture), store in clean, dry, closed cabinet (sterile storage; shelf life depends on wrap quality (event-related sterility - sterile until package is damaged/wet)), maintenance (daily: clean exterior, check water level, empty waste, inspect door seal (wipe clean), check display; weekly: clean chamber (wipe, remove scale/debris), clean trays, check vacuum pump oil/water (if applicable), run Bowie-Dick; monthly: replace water filters, inspect valves/gaskets, clean steam generator (descale if needed), semi-annually/annually: professional preventive maintenance (vacuum pump, valves, heating elements, temperature calibration, pressure gauge calibration, leak test, software update), water quality (use only distilled/RO/demineralized water; test water quality periodically; tap water = scaling = damage), troubleshooting (cycle fails/vacuum error (door seal leak (replace/clean), chamber leak, vacuum pump failure, clogged filter, water supply issue - inspect seal, service pump, replace filter; do not use until fixed), wet packs (overloaded, cycle too short, post-vacuum inadequate, door seal leak, cold room condensation - reduce load, extend dry, check seal, warm room), Bowie-Dick fail (air leak (door seal, chamber), vacuum pump weak, blocked drain - service; do not use until fixed), BI positive (sterilization failure - possible causes: overload, poor cleaning, cycle error, BI expired; quarantine, investigate, 3 negative BIs before return), temperature not reaching (heating element failure, steam generator issue, scale buildup, sensor error - service, descale), door will not open (pressure not released (wait), interlock fault, seal stuck - release pressure, service), and safety (PRESSURE/HEAT HAZARD (autoclave operates at 121-138 degrees C, 15-30 psi; steam burns are severe - do not open door while pressurized (interlock prevents, but verify pressure = 0 before opening), use heat-resistant gloves, face shield when unloading hot items, allow cooling; do not lean on door), STEAM EXHAUST (vent to outside or adequate ventilation - hot steam/condensate; do not direct at people/electronics), WATER QUALITY (use only distilled/RO/demineralized water; tap water causes scaling, corrosion, valve damage, chamber pitting - expensive repairs; do not use additives), CHEMICAL (disinfectants/cleaning agents for chamber - use manufacturer-approved; do not use bleach/chloride (corrodes stainless steel)), BIOLOGICAL HAZARD (processing biohazard waste, contaminated instruments - handle with PPE (gloves, gown, eye protection), decontaminate spills; ensure waste is properly contained before sterilization), ELECTRICAL (high-power device - dedicated circuit, proper grounding, do not use with wet hands), do NOT sterilize: sealed containers (explosion risk - loosen caps), liquids in vacuum cycle (boil-over/explosion - use liquid cycle only), flammable/volatile chemicals (fire/explosion), radioactive materials, items not approved for steam (some plastics (only PP/PC autoclavable), electrical items, optics, adhesives - check IFU), do not overload (blocks steam = sterilization failure), for implants: BI must be negative before release (unless emergency with documented risk per AAMI)) are critical for safe and effective steam sterilization.

Q5: What is the typical lead-time for order delivery?

A: Standard models require 7-30 working days. In-stock units can ship within 3-7 working days. Custom configurations or large built-to-order systems may require additional time, and we confirm the exact schedule before order confirmation.

Q6: Is regular calibration required? What is the recommended calibration cycle?

A: Calibration/performance verification recommended every 6-12 months (or per quality system/regulatory) by manufacturer or certified technician: temperature calibration (thermocouple verification at chamber center and cold spot - traceable to national standards; accuracy +/- 0.5 degrees C typical), pressure gauge calibration (traceable), timer calibration, vacuum leak test (rate of pressure rise - per EN 285/ISO 17665), and safety valve test. Routine monitoring (required, not just calibration): Bowie-Dick test DAILY (first cycle, for pre-vacuum air removal - AAMI ST79, ISO 11140-4), chemical indicator in EACH package (class 4/5/6), biological indicator WEEKLY and every implant load (G. stearothermophilus, with positive control), cycle parameter record (temperature, pressure, time - printout/electronic for each cycle). Full annual preventive maintenance (vacuum pump, valves, heating elements, door seal, descaling, calibration) by manufacturer. For CMS/Joint Commission/GMP accreditation, follow applicable schedules and maintain records (calibration certificates, maintenance logs, Bowie-Dick results, BI results, cycle records). Steam sterilization is critical for patient safety - regular maintenance and monitoring are essential; many facilities have service contracts for autoclaves (downtime is high-risk). For pharma/medical device: revalidation annually or after major repair (per ISO 17665, PQ).

Q7: Are supporting consumables universal?

A: Sterilization wrap (two-layer non-woven (SMS) or reusable woven - universal from medical supply (Halyard, Cardinal, Medline) but use approved for steam), chemical indicators (class 4/5/6 integrators/indicators - universal (3M, Crosstex, Steris) but match to cycle type), biological indicators (G. stearothermophilus spore strips/vials - universal (3M, Mesa, Raven, Terragene) but use per standard), Bowie-Dick test packs (specific for pre-vacuum - universal (3M, etc.)), door seal/gasket (specific to autoclave model), trays/racks (specific to chamber size), water filter (specific), and cleaning supplies are available from medical/lab supply companies, though door seals, trays, and filters are autoclave-specific (use OEM or certified compatible to maintain performance and warranty). Long-term consumable cost includes wrap, indicators, BI (per cycle - moderate), and periodic door seal/filter replacement.

Q8: Can I customize parameters or supporting accessories?

A: Customization includes chamber size/capacity (tabletop (18-60 L, small clinic/dental/lab), under-counter/floor (100-300 L, hospital CSSD), large (500-1000+ L, pharma/medical device manufacturing, hospital central sterile)), cycles (pre-programmed: wrapped (134 degrees C/3-5 min), unwrapped (134/3 min), porous/textiles (121/134), liquids (121/15-30 min, no vacuum, slow exhaust), glassware, custom user-programmable cycles), vacuum (pulse vacuum (fractionated, 3-5 pulses) or single pre-vacuum; post-vacuum drying), control (analog or digital (touchscreen, cycle parameter display, data logging, USB/network export, 21 CFR Part 11, barcode/RFID for load tracking), steam source (built-in electric steam generator or connected to facility steam), water system (built-in reservoir (distilled water) or direct connection to RO/demineralized water; water quality monitoring), construction (stainless steel 316L chamber, jacketed chamber, insulation, safety interlocks (door lock, pressure relief valve, over-temp protection)), accessories (extra trays/racks, instrument cassettes, sterilization wrap (initial), chemical/biological indicators (initial), Bowie-Dick tests, water filter, printer, validation package (IQ/OQ/PQ), training, service contract, certifications (FDA 510(k), CE MDR, NMPA, ASME/PED pressure vessel, ISO 17665, AAMI ST79 compliance), language and accessories. Additional consumables and accessories can be ordered separately.

Q9: Does the purchase include on-site installation and commissioning service?

A: Standard delivery includes pulse vacuum autoclave, trays/racks, power cord, and instruction manual. On-site installation, qualification (IQ/OQ), and operator training ARE typically included or strongly recommended for autoclaves (medical/pressure devices requiring professional installation (utility connections, water treatment, ventilation), performance validation (Bowie-Dick, temperature mapping, leak test), and user training on loading, cycle selection, monitoring (BI/CI), and regulatory compliance; installation by manufacturer or certified biomedical technician is standard, and hospitals/pharma require IQ/OQ for accreditation). For small tabletop models: self-installation possible (connect water/drain/power) but calibration/validation and training still recommended. Always verify with Bowie-Dick, chemical indicator, and biological indicator before clinical use.

Q10: What types of samples are compatible with this equipment?

A: The pulse vacuum autoclave sterilizes heat- and moisture-stable items including surgical and dental instruments (stainless steel forceps, scissors, scalpels, handpieces, burs, mirrors - wrapped or unwrapped; hollow instruments with lumens (vacuum removes air)), laboratory glassware (beakers, flasks, pipettes, bottles, petri dishes - clean, dry, covered with foil/cap (loose)), culture media (agar, broth - liquid cycle only (no vacuum, slow exhaust); fill containers <2/3 full, loosen caps), textiles (surgical gowns, drapes, linen, lab coats - wrapped, porous loads), plastics (only autoclavable types: polypropylene (PP), polycarbonate (PC), PTFE, PMP; NOT polystyrene (PS), PVC, LDPE (melts/deforms) - check resin identification code #5 PP or #7 PC), rubber/silicone (tubing, stoppers, gaskets - autoclavable but may degrade over repeated cycles), biohazard waste (contaminated materials, cultures, animal carcasses (if rated) - decontaminate before disposal), and equipment parts (stainless steel, glass, autoclavable plastic components). NOT compatible with: Liquids in vacuum cycle (boil-over, explosion - use liquid cycle with no vacuum and slow exhaust), sealed/airtight containers (pressure buildup = explosion - loosen caps, use vented closures), flammable/volatile chemicals (ethanol, methanol, acetone, solvents - fire/explosion; do not autoclave), oils/greases (not penetrated by steam, can ignite; use dry heat/other method), radioactive materials (contamination risk), items damaged by heat/moisture (electronics, optics, adhesives, some plastics (PS, PVC), paper (can char at 134, OK at 121 if not too long), sharp instruments (can dull over repeated cycles - use low temp or other method if critical)), and items with residual organic soil (must clean first - soil protects microbes, sterilization fails). IMPORTANT: Pulse vacuum autoclave fundamentals: (1) What it does: Sterilizes using saturated steam under pressure. Steam at 121 degrees C (15 psi) or 134 degrees C (30 psi) kills microorganisms (including bacterial spores) by denaturing proteins/enzymes. Pulse vacuum removes air before sterilization (air prevents steam contact) and removes moisture after (drying). Sterility Assurance Level (SAL) 10^-6 (probability of one surviving microbe <1 in 1,000,000). (2) Why pre-vacuum? Air is the biggest barrier to steam sterilization. In a gravity displacement autoclave, steam pushes air out the drain - but air can be trapped in wrapped packs, lumens, porous loads, creating cold spots (air = insulator, steam cannot reach). Pre-vacuum (pump air out, inject steam, repeat 3-5 pulses) removes >99% of air, ensuring steam penetrates everywhere. Required for: wrapped instrument trays, hollow devices (endoscopes, handpieces), porous loads (textiles), complex loads. Bowie-Dick test verifies air removal (daily). (3) Cycle phases: 1. Pre-vacuum: 3-5 pulses of vacuum + steam injection. Removes air. 2. Ramp: Steam injection raises temp/pressure to set point. 3. Exposure (sterilization): Hold at 121 or 134 degrees C for specified time (121: 15-30 min; 134: 3-5 min for wrapped, 10 min for porous). Time at temp is critical. 4. Exhaust: Remove steam (fast for dry loads, slow for liquids to prevent boil-over). 5. Post-vacuum drying: Vacuum removes residual moisture/condensate. Drying is critical - wet packs = contamination risk (microbes can wick through wet wrap). (4) Temperature/time: - 121 degrees C (250 degrees F, 15 psi): Standard for media, glassware, liquids, heat-sensitive items. 15-30 min exposure. - 134 degrees C (273 degrees F, 30 psi): Faster, for wrapped instruments, porous loads. 3-5 min (wrapped), 10 min (porous/textiles). Higher temp = shorter time but more material stress. (5) Monitoring (per AAMI ST79, ISO 17665): - Mechanical: Each cycle - monitor temp, pressure, time (printout/electronic). - Chemical: Each package - internal chemical indicator (class 4/5/6) changes color when exposed to correct conditions. External indicator on tape/wrap. - Biological: Weekly + every implant load - G. stearothermophilus spores (10^6 CFU). Incubate 24-48 h at 55-60 degrees C. Positive = failure. - Bowie-Dick: Daily (first cycle) for pre-vacuum - tests air removal. Failed = do not use. (6) Loading principles: - Clean items first (soil = sterilization failure). - Disassemble, open hinges, flush lumens. - Wrap properly (two layers, not too tight, chemical indicator inside). - Load on edge, not flat; leave space; do not overload. - Textiles top, metal bottom (prevent condensate drip). - Hollow items tilted, lumens down/horizontal. - Liquids separate (liquid cycle, no vacuum). - Do not block drain/vacuum ports. (7) Common errors: - Poor cleaning (biggest cause of sterilization failure - bioburden protects microbes). - Overloading (blocks steam circulation, wet packs). - Wrong cycle (liquids in vacuum cycle = explosion; use liquid cycle). - No Bowie-Dick (air removal failure undetected). - Wet packs (post-vacuum inadequate, overload, cold room - reprocess). - BI not run weekly (cannot verify sterilization). - Using tap water (scaling damages chamber/valves - use distilled/RO). - Sealed containers (explosion risk). - Flammable materials (fire/explosion). - Not cooling before storage (condensation = wet pack). - Ignoring cycle failure (if temp/time not met, load is NOT sterile - reprocess). (8) Autoclave classes (EN 13060 for small): - Class N: No vacuum, gravity displacement. Only for unwrapped, solid, non-porous items. - Class S: Limited vacuum (one pre-vacuum). For specific wrapped/porous loads (per manufacturer). - Class B: Pulse vacuum (multiple pre/post vacuum). For all load types including wrapped, hollow, porous. Hospital/dental standard. This autoclave is Class B (pulse vacuum). (9) Water quality: Use only distilled, deionized, or RO water (resistivity >0.1 Mohm-cm, chloride <5 ppm, silica <1 ppm). Tap water minerals deposit on chamber, valves, sensors = scaling, corrosion, inaccurate temp, valve failure, expensive repairs. Check/clean steam generator regularly (descale). (10) When sterilization fails: - Quarantine/recall affected load (if released). - Investigate: loading, cleaning, cycle, water, equipment. - Service/repair. - Run 3 consecutive successful BI tests before returning to service (AAMI ST79). - Document everything.