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Device Lab 18

Autoclave

Autoclave in the BMEssentia 3D Device Lab

Steam admitted at the top of the chamber and air allowed to fall out of a drain at the bottom. There is no pump, no sub-atmospheric step and nothing at all driving the air except the fact that it is denser than steam. The holding condition is a hundred and twenty-one degrees for fifteen minutes, and the extra twelve minutes over the pre-vacuum cycle are being spent on the same lethality at a lower temperature.

Also called: Steam Steriliser, Steam Sterilizer. Arabic: جهاز التعقيم بالبخار. Device Lab 18 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Gravity displacement, solid and fluid loads

Steam admitted at the top of the chamber and air allowed to fall out of a drain at the bottom. There is no pump, no sub-atmospheric step and nothing at all driving the air except the fact that it is denser than steam. The holding condition is a hundred and twenty-one degrees for fifteen minutes, and the extra twelve minutes over the pre-vacuum cycle are being spent on the same lethality at a lower temperature.

Pulsed pre-vacuum, porous and hollow loads

A liquid-ring pump pulls the chamber down to about a tenth of an atmosphere, steam refills it to roughly two bar, and the sequence repeats. Only after that does the temperature phase begin, which is why the cycle chart on the wall of a sterile services department is mostly a sawtooth with a plateau on the end. The holding condition is a hundred and thirty-four degrees for three minutes.

How it works: the main parts

What each part does, from the Autoclave lessons in the 3D Device Lab.

Chamber vessel and pressure boundary
A rectangular stainless steel box with radiused corners, about six hundred and sixty millimetres each way and a little deeper, welded from five-millimetre plate, with an aperture at each end and a shallow sump in the floor. Three hundred litres.
Steam jacket and insulation
A second shell about twenty millimetres outboard of the chamber, forming a closed annular space around five of its six faces, filled with steam at its own pressure. Outside that, fifty millimetres of insulation blanket, and outside that the painted cladding panels a person actually touches.
Door, seal and interlock
A stainless slab with a stiffening rib, a viewing port on the clean side, rising vertically into a headbox above the aperture on a pneumatic ram and a chain. Around the aperture, a hollow silicone gasket in a groove.
Loading carriage, shelves and the load
A stainless frame on four castors with a perforated or wire deck at nine hundred millimetres, a second shelf above it, and a push handle. On it: trays, wrapped packs, pouches.
Plant steam supply, isolation and separator
A lagged pipe dropping from the ceiling on the service side, with an isolating valve and its hand-wheel, a Y-pattern strainer, and a separator: a small vessel with a baffle in it and its own trap on the bottom. A pressure gauge reads what arrives before anything is done to it.
Pressure-reducing valve and the superheat it makes
A cast body with a large spring bonnet on top, an adjusting screw and a lock nut, a small pilot line running back from downstream, and a gauge on the outlet reading the pressure the chamber will see. It is a regulator rather than a restrictor: it holds a set outlet pressure regardless of what the inlet does.
Integral steam generator and feedwater
A short fat pressure vessel with domed ends under the chamber, about two hundred millimetres across and three hundred tall, with a bolted element flange low on one side, a sight glass and two level probes, a feedwater pump, a softener cartridge and a blowdown valve at the lowest point.
Chamber admission valve and baffle
A diaphragm valve body high on the machine with a pneumatic actuator on top of it and a small solenoid pilot beside that, feeding a pipe that enters the chamber through the jacket and the insulation at the top. Inside the chamber, the pipe ends at a spreader rather than at an open end.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Leak/Splash314
Fluid/Blood Leak193
Device Fell71
Device Operates Differently Than Expected71
Component Falling67
Device Tipped Over42

Raw counts of adverse event reports for this device type (FDA product code FLE), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.

Planned maintenance checks

From the BMEssentia procedure library: every 12 months, about 240 minutes, electrical class I.

Periodic tests follow HTM 01-01 / EN 285 for porous-load sterilizers. The annual thermometric test is done by an authorised person (sterilizers).

CheckPass when
Door, seal and chamber
Inspect the door seal, the interlocks, the chamber drain and strainer, the safety valve and the recorder.
Seal intact; door cannot open under pressure.
Electrical safety
Test the sterilizer's mains supply and earth bonding as a Class I appliance (it has no applied part).
Protective earth ≤ 0.30 Ω (or the installation's limit for fixed equipment).
Vacuum leak test
Run the vacuum leak test cycle and read the rise in pressure over the test period.
≤ 1.3 mbar/min.
Thermometric test
Run a full porous-load cycle with sensors in the chamber drain and the test pack; read equilibration time and the holding temperature band.
Equilibration ≤ 15 s; the sterilization band and holding time of HTM 01-01 Part C held.
Safety devices
Prove the door interlock, the over-temperature cutout and the safety valve operation as the manufacturer specifies.
Each operates at its set point.

Test instruments: Thermometric recorder with chamber and load sensors; Calibrated pressure reference; Bowie-Dick test pack.

Standards engineers test against

ISO 15883: washer-disinfectors

The series for washer-disinfectors: part 1 general requirements, part 2 for surgical instruments, part 4 for flexible endoscopes.

EN 285 and ISO 17665: steam sterilization

EN 285 covers large steam sterilizers; ISO 17665 covers the development, validation and routine control of moist heat sterilization.

Recent FDA recalls

RecallProduct and reason
Z-2983-2026
2026-08-18
Fort Defiance Industries, LLC: Fort Defiance Industries (FDI), Automated Field Steam Sterilizer
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path. Root cause: Component design/selection.
Z-2285-2023
2023-08-03
Scican Ltd.: STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize
The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Root cause: Employee error.
Z-2286-2023
2023-08-03
Scican Ltd.: STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize
The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Root cause: Employee error.
Z-0121-2022
2021-08-19
Fort Defiance Industries, LLC: P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground. Root cause: Device Design.
Z-0586-2020
2019-10-22
Steris Corporation: Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward Root cause: Process control.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 18 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

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