Model

Internal Dimensions
wxhxd

External Dimensions
wxhxd

Volume
liters

Capacity
cu.ft.

MB-6212

48" x 86" x 92"

144" x 133" x 92"

6212

219.4

Our bulk sterilizers (autoclaves) are commonly found in pharmaceutical companies, vivariums, USDA research facilities, Biotech facilities and University laboratories. These are designed for highly effective sterilization of hard goods, pours material and liquid applications in the laboratory field utilizing clean saturated steam as the sterilization medium.

Sterilco cGLP steam sterilizer fulfills the stringent requirements of the current Good Laboratory Practices (cGLP's).

All of our sterilizers can be custom made to fit the needs of user.

Technical Specification

Mountings

The sterilizer can be constructed as a single or double-door pass-through unit and can be mounted in one wall or between two walls.

The sterilizer is designed to be mounted in a 24” deep pit, which will allow the chamber floor to be even with the facility floor for ease in loading and unloading. The sterilizer comes with ramps to cover the gap between edge of the pit and the chamber floor. The ramps are designed to be manually raised and lowered according to the door position.

Qualification

Construction meets or exceeds the requirements or recommendations of:

  • cGLP Current Good Laboratory Practices
  • IMHS Industrial Moist Heat Sterilization: International Standard 11134:1994
  • ASME American Society of Mechanical Engineers
  • UL Underwriters Laboratory
  • CETL Canadian Testing Laboratories (for conformance to CSA)
  • NFPA National Fire Prevention Association
  • OSHA Occupational Safety and Health Administration
  • NPC National Plumbing Code
  • NEC National Electrical Code
  • NEMA National Electrical Manufacturers Association

Chamber

Constructed in accordance with ASME Section VIII, Division 1, for unfired pressure vessels and so stamped for 45 psig/144 °C Design Temperature and Full Vacuum. The chambers are rectangular in design and fully jacketed.

The chamber is 316L stainless steel with fully welded construction. Steam baffles are positioned in the chamber to minimize wetting by condensate and ensure proper steam distribution within the chamber.

Jacket

The jacket is constructed of 316L stainless steel, is ASME stamped for 45 psig/144 °C Design Temperature, and mounted to the chamber with our unique double-plate beam construction. C-channels are stitch welded to the exterior of the chamber to allow for maximum expansion and contraction without the risk of cracking the weld. An additional stainless steel plate is welded over the C-channels to create a complete steam jacket, which allows for jacket steam penetration within and in between the C-channels. This unique jacket construction allows for very tight chamber temperature distribution, decreases the time needed to bring the chamber up to sterilization temperature and prevents the formation of condensate on the chamber walls.

Doors

Horizontal Sliding Door

The sterilizer is equipped with horizontally sliding doors. The horizontally sliding doors are pneumatically powered and opened and closed via the OIT. The door is equipped with a leading edge strip that automatically reverses the door should an obstacle be in the door way. In addition, the door cylinder utilizes a low-pressure air system equipped with pressure relief valve to ensure that the pressure cannot build in the system and allows easy override of the door. The door open button is a momentary contact; however, the door close button must be continually depressed during movement. The door will automatically reverse if the door close button is released.

The door is sealed by filtered air pressurizing the continuous O-ring gasket, which is recessed within the chamber head ring against the door. The gasket is retracted by vacuum before the door is opened. Double-door units are safety interlocked so only one door may be opened at one time, which ensures the proper flow from load side to unload side.

Insulation

The exterior of the jacket is covered with 2” thick chloride-free insulation. The insulation is encased within sturdy stainless steel and sealed for water tightness.

Frame

The sterilizer chamber is secured to a welded structural frame. The frame is constructed of 304 stainless steel. Adjustable screws at the base of the frame allow for leveling during installation. The sterilizer is constructed in a modular form which allows for easy breakdown of the unit to aid in moving through doors and hallways during installation.

Steam Bleed

The chamber drain is equipped with a bleed valve that enhances the movement of steam within the chamber and through the bleed lines. The constant flow past the drain RTD ensures accurate temperature control.

Piping

Piping on the sterilizer is constructed from brass or copper. All plumbing fixtures and components are readily accessible and removable without requiring major disassembly of the unit.

Steam Traps

The steam traps are thermostatic, non-proprietary, industrial-grade, and are positioned and sized for maximum efficiency for the removal of air and condensate from the system.

Valves

All control valves are non-proprietary, industrial-grade and pneumatically operated. Chamber steam control is provided by two on/off control valves to provide chamber temperature control within ± 1°C or better throughout the chamber during exposure.

Overpressure Relief

The chamber and jacket are protected from over-pressure by ASME stamped safety relief valves. Safety relief devices are factory preset for the vessel design pressure.

Validation and Load Ports

The chamber is equipped with two stainless steel sanitary, 1 ½” tri-clamp ports for use for validation and one sanitary, clamp-type port for use for a load probe(s) if equipped. Each is constructed of and equipped with blind flanges. They are located in the maintenance space for easy accessibility and are sloped towards the chamber for proper drainage. Additional ports can be ordered as an option.

Vacuum Pump

The liquid ring vacuum pump efficiently removes air from the chamber prior to the sterilization of wrapped or porous loads. A deep vacuum during the drying step also ensures permeable loads are free of trapped condensate when removed from the chamber.

Air Filter

Chamber air routes through a 0.2 micron sanitary hydrophobic filter.

Exhaust Cooling System

Exhaust cooling protects the facility drainage system by automatically mixing effluent with cooling water to reduce the temperature to an acceptable level. A temperature sensing device located in the exhaust drain opens a mixing valve to introduce cooling water whenever the temperature exceeds the set point. This feature greatly reduces cooling water consumption. Discharge temperature is influenced by the temperature of the cooling water supplied; however, it will typically be 60 °C (140 °F) or less when cooling water is 21 °C (70 °F) or less.

Control System

Siemens PLC Control System

The Siemens S7-200 PLC provides automatic control of all the sterilizer functions. The PLC is equipped with a central processing unit providing high-level data access through an RS 232 network. The PLC is mounted in a UL Listed NEMA 4/12 panel.

A LCD display with touch screen function is provided for operator control, cycle programming and indicates the sterilizer operating state. Alarms are announced audibly and indicated in clear text. The operator interface is mounted on the front fascia, on the loading side of the sterilizer.

Double door sterilizers are equipped with a digital operator interface panel for door operation and cycle progress monitoring

The software is configured to GAMP 4 regulations as follows:

  • Up to 20 programmable cycles are available with a wide range of settable parameters, which provides for a high degree of functionality and allows great freedom in designing cycles for various products.
  • Cycles 21 and 22 are reserved for a Vacuum Leak Test and the optional Filter Sterilization Cycle
  • Three Level Pass code protection Level 3 – Operator level: Allows access to the operation screens to select a cycle and run the selected cycle
    Level 2 – Supervisor level: Allows access to the operation and the cycle management screens
    The cycle management screens allow setting and storing program parameters.
    Level 1 - Engineer Level: Allows access to the operation and service screens for calibration of RTD’s, control analog inputs, discrete inputs and discrete outputs, management of date and time, and password management.
  • All messages, alarms and interlocks are expressed in user friendly full text
  • System home screen enables quick user navigation between all displays
  • Operation
    • Operation features are governed by the pass code level assigned
    • System information: System mode, active alarm status, current user and date/time.
    • Loaded recipe information: Recipe, phase and step.
    • Step messages
    • Interlock messages
    • Process variables with set-points
    • Door and gasket status
      • Interlock prevents door operation if the chamber is not sterile.
      • Powered door safety bar – reverses door if an obstruction is detected.
      • Chamber steam is interlocked with the door position switches. If an open door is detected than chamber steam is not allowed to activate.
      • Chamber pressure interlock prevents door operation if there is pressure inside the chamber.
      • Programmable temperature interlock prevents door operation if the temperature exceeds the set point.
      • Annunciator silence
      • PID control of temperature
      • Single display for ease of viewing and controlling
  • Process setup provision for modifying global process settings (requires authorization by administrator)
  • Real time active alarm status
  • Active interlock status
  • Date\time editor
  • System I\O status and in the service mode, control of outputs and system functions
  • Reports:
    • Full report time stamped logging that includes recipe information, phase sequence, step sequence, data capture and alarms.
    • Fast printing by directly utilizing the PLC onboard serial port.
    • Recipe parameter report
  • Electrical
    • Emergency Stop button located on the loading side and if a double door unit on the unloading side
    • The PLC is enclosed in a UL 508, NEMA 4 box.
    • Ethernet port built-in
    • Inputs, Outputs and HMI’s and pushbuttons are low voltage 24 VDC.
    • Control valves feature low power wattage consumption
    • Control panels feature finger safe design
    • All outputs are fully fused I order to provide operator safety, equipment safety and simplified trouble shooting

Data Logger (Sterilizer Report Printer)

The data logger provides digital printout of cycle progression and information including any fault statements during the entire cycle. The following process parameters are recorded on the 24-character 2¼” impact printer with take-up reel.

  • Date
  • Sterilizer identification
  • Load identification
  • Operator identification
  • Cycle parameters
  • Cycle start time (real time)
  • Initiation of steam charging
  • Chamber pressure
  • Chamber temperature
  • Exposure start time
  • Exposure end time
  • Cooling time/final temperature
  • Alarms if any (real time)

Temperature Control

A Resistance Temperature Device (RTD) is placed in the drain line (coldest spot of the chamber) to sense and control temperature within the chamber. The RTD emits a signal to the PLC which in turn controls the chamber steam valve.

Temperature Distribution

The temperature distribution is within ±0.1 °C of set point throughout the chamber during sterilization. Temperature readout and printout are provided in 0.1 °C increments.

Chamber and Jacket Pressure Displays

The chamber pressure and temperature and jacket pressure is displayed on pressure gauges mounted above the chamber.

Pressure / Temperature Sensors

An analog pressure transducer senses chamber and jacket pressure. Chamber and jacket temperatures are sensed by platinum RTD’s.

Standard Cycle Descriptions

Dry Goods - Vacuum Cycle (Standard)

This cycle provides effective sterilization of hard goods, rubber stoppers, filters, linens, and other porous materials, wrapped goods, and product that is unaffected by vacuum. The load is preconditioned utilizing vacuum and steam pulses. The cycle then advances to heat-up and continues till it reaches the settable exposure temperature of 110 °C up to 135 °C. Once the exposure temperature set point is reached, the controller counts down the exposure time. After the exposure time is completed, drying begins and can be accomplished by fast exhaust, deep vacuum or vacuum pulses which is highly effective at removing moisture from the load.

Solution Cycle - Gravity Air Removal / Ramped Exhaust (Standard)

This cycle effectively sterilizes liquid products or items in vented or sealed glass containers. The load is preconditioned utilizing steam pulses. The cycle then advances to heat-up and continues till it reaches the settable exposure temperature of 110 °C up to 135 °C. Once the exposure temperature set point is reached, the controller counts down the exposure time. After the exposure time is completed, Exhaust ramping gradually returns liquids to a temperature below boiling.

Factory Testing

The sterilizer is extensively tested at our factory prior to shipment to ensure a trouble free start-up of the sterilizer once it arrives at the purchaser’s facility. Tests include mechanical check out, electrical check out, control system check out, input/output testing, alarm initiation testing, operational check out.

Standard Documentation Package

Design Qualification

  • Piping and Instrumentation Diagram
  • Installation Drawings
  • Electrical Diagrams
  • Control System Documentation
  • Software Source Code Listing
  • Installation Manual
  • Operational Manual
  • Mechanical Component Parts List
  • Electrical Component Parts List
  • Mechanical Component Catalog Cut Sheets
  • Electrical Component Catalog Cut Sheets
  • Factory test results