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Alfa Medical
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Great Neck NY 11021
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cGMP Steam Sterilizer 

Technical Specification 

This specification details the features of the Alfa Corporation cGMP Steam Sterilizer. The Alfa cGMP Steam Sterilizer is designed for the decontamination of hard goods, textiles, and liquids in vented or open containers according to the requirements of the Food and Drug Administration regulation 21CFR and AAMI / ISO 111345-R-8/93 Industrial Standards for Moist Heat Sterilization. An automatic leak test is provided to periodically check chamber seal integrity.

An independent cycle to sterilize the air admission filter (insitu) is provided as optional. 

Steam Sterilization Cycles 

The Alfa cGMP Steam Sterilizer offers 10 selectable cycles, as standard, including six (6) Prevacuum cycles, three (3) liquids (open containers) cycles, and one (1) automatic leak test. One (1) Insitu Filter cycle is provided if the option is selected. Additional cycles can be added upon request and customized specifically for the application. Cycles follow the guidelines for Industrial Moist Heat Sterilization referred to in document AAMI / ISO 111345-R-8/93. 

Through the user-friendly operator interface on the sterilizer’s control panel the user can configure, select, and start sterilization cycles. The system allows the end user to customize individual cycles to the products and goods to be sterilized. 

The following parameters can be configured for the Prevacuum Cycles: sterilization exposure time, sterilization temperature, number of air evacuations, evacuation pressure depth, temperature overdrive, drying time, and drying pressure depth. 

The following parameters can be configured for the Liquid Cycles: sterilization exposure time, sterilization temperature, air displacement time, equivalent sterilization time F0, temperature overdrive, and cooling ramp rate. 

All cycle parameters are password protected. Sterilization temperature setpoints are selectable in the range of 105oC to 135oC. 

For liquid cycles, load probe(s) can be provided to sense the liquid temperature and to initialize the sterilization timer in order to provide precise control over the temperature of the media. 

Sterilization exposure periods can be controlled by time vs temperature methods or through the use of equivalent sterilization F0 calculations. 

Alfa Corp. guarantees the chamber control to be within +/- 0.5 oC for all cycles. Temperature uniformity to be within +/- 0.5 oC. 


Control System 

The Alfa Corporation cGMP Steam Sterilizer can be provided with the Alfa Model 2002 series Controller and operator interface or an optional Allen Bradley SLC 5/04 programmable logic controller (PLC) with PanelView 600 touch screen operator interface. 

Both Control systems are designed to meet FDA 21 CFR part 11 – “Electronic Signatures”. Software is developed according to Life Cycle Methodology.

The Alfa model 2002 Microprocessor Control System utilizes 12 bit resolution over a range of 25 oC to 150 oC giving a capability to achieve less than 0.1oC control accuracy. Features of the model 2002 controller include PID functions, floating point math, 24 configurable digital inputs and outputs expandable to 48 I/O, 0-10V analog input, 10BASE-T Ethernet communications for remote data acquisition, 517K flash memory, and 128K NVSRAM memory with 10 year battery backup. 

The controller is a single board embedded microprocessor which includes: 80386EX microprocessor, keypad port, LCD port, printer port, watch dog timer, two (2) RS-232 serial ports, eight (8) channel analog inputs (0-10V), 4 channel analog outputs (0-10V), and 24 configurable inputs and outputs. The system is expandable to 48 I/O. 

The user-friendly operator interface consists of a four (4) line / 20 character alpha numeric liquid crystal displays to display process variables, an operator input keypad, and a program / run key switch for security access to system and cycle parameters. LED indication lamps are also provided to indicate power, control door locked, and remote door locked. 

The optional Alfa Allen Bradley Control System consist of a non-proprietary Allen Bradley SLC 5/04 Programmable Logic Controller (PLC) utilizing 16 bit resolution giving a capability to achieve less than 0.1oC control accuracy. Features of the SLC 5/04 controller include PID functions, floating point math, 24VDC discreet inputs and outputs, 4-20 mA analog input, three (3) levels of password security, Ethernet communications, and 72 hour back-up memory. 

The controller interfaces with an Allen Bradley PanelView 1000 ten inch (10”) color touch screen operator interface located on the sterilizer’s control console. The operator interface utilizes three (3) levels of password security to protect the integrity of the system and against unauthorized changes to the system or cycle parameters.

The controller is housed in a Nema 4 painted gray electrical enclosure. A power disconnect switch is provided on the enclosure. 

Double door sterilizers can be provided with either pushbutton or full redundant controls on the unload side of the sterilizer. 

Chamber and jacket temperatures are controlled independently using PID temperature control. 

As part of the cGMP requirements for the sterilizer, the sterilizer’s chamber temperature is sensed by a dual 100 ohm platinum RTD located in the sterilizer’s drain pipework. One element is used in the sterilizer’s chamber temperature control scheme while the second element is connected to a digital temperature display located on the control panel. Jacket temperature is sensed by a 100 ohm platinum RTD located in the jacket.

Chamber pressure is sensed by a pressure transducer attached to the side of the chamber. Load temperature is sensed by the chamber load probe (if supplied). A third RTD is located in the sterilizer’s drain to sense when condensate is accumulating. 

For the Insitu Filter cycle, the filter temperature is sensed in the downstream path of the filter. Upstream and downstream bleeds are provided around the filter to remove condensate and to insure sterility of the filter. 


Data Acquisition 

Cycle data is logged real time to a 40 column impact printer . Data collected is in accordance with FDA 21 CFR part 11- Electronic Signatures. 

Data acquisition for each cycle includes: 

Print Header containing: cycle name, date, sequential cycle number, user indentification, time, sterilizer indentification number, and current cycle parameters 
Time stamps and indication for start of cycle, change of phase, alarms, and end of cycle 
A signature and date acknowledgement are provided at the end of the printout. 
Cycle sterilization summary 


Chamber Design 

The sterilization chamber is constructed of 316L stainless steel and is polished to a minimum 20 Ra internal finish. The chamber is a fully jacketed construction using 304 stainless steel. Chamber and jacket are independent and are rated for 50 psig and full vacuum at 150oC as certified by ASME section 8, division I pressure vessel code. 

The chamber is insulated using chloride-free insulation covered with polished aluminum cladding. All chamber ports are triclamp connections. Jacket ports are threaded 150 lb rated connections. A triclamp validation port is provided on the service access side of the sterilizer for insertion of thermocouples for validation studies. 

Door System 

The cGMP sterilizer is provided with either vertical or horizontal doors 
In manual or power door configurations. Door(s) are constructed of 316L stainless steel and are polished to a minimum 20Ra on the chamber interface side. Door(s) are fully insulated and are covered with #4 polished 304 stainless steel to match the sterilizer’s front panels. 

For double door units, pass-through door operation is utilized to prevent cross-contamination from load to unload sides of the sterilizer. In the event of an aborted cycle, the load is returned to the loading side. 

For horizontal door units, a door lock-out key switch is provided to lock the door in either the open or closed position during times of maintenance or cleaning of the chamber. 

Door Safety Interlocks are standard for all Alfa sterilizers. These include: 

§ Door limit switch to determine closed position of the door 

§ Pneumatic interlocks to prevent the chamber or door seal from being pressurized with air while the door is open. 

§ Mechanical lock on the door to prevent opening during a cycle 

§ Physical mechanical stops for the door in the event of a catastrophic overpressure within the chamber. 

§ Two (2) Electrical interlocks to prevent the chamber from being opened while chamber is under pressure. 

§ Pass-through design to prevent cross- contamination from load to unload sides of the sterilizer. 



Cross-contamination Seal 

A cross-contamination seal can be provided as an option as an integral part of the sterilizer. 304 stainless steel panels are utilized to seal the periphery of the sterilizer to the recessed wall opening. All seams are sealed using clear RTV silicone sealant to insure bioseal integrity. 

Piping Design 

Standard piping for the cGMP steam sterilizer utilizes 316L sanitary orbital welded tubing and tri-clamp connections for the chamber process piping (clean steam, air, and to first isolation valve in sterilizer drain). Standard internal finish for stainless steel piping is 180 grit polish. 

All stainless steel welds are inspected by borescope or visual inspection methods. A weld certificate is provided as standard documentation insuring compliance to the Alfa welding standard. 

A safety relief valve (316L wetted parts) in accordance with ASME code, sanitary rupture disk, and pressure switch for burst detection is provided for the chamber. Weld-in-place pneumatic piston globe valves are incorporated in the piping design to insure durability and low maintenance. Care is taken in the fabrication of the pipework to insure deadlegs are minimized to less than 6:1 ratio and that the pipework is free-draining. 

Brass and copper construction is used for the jacket piping and all non-process lines. 


Jacket is provided with a bronze safety relief valve in accordance with ASME code. 

All safety relief valves are set for 50 psig and sized per ASME code. 

Steam traps are provided at low points in the piping system. A drain condenser is provided to reduce the chamber exhaust temperature to below 140oF to comply with all local plumbing codes. Process chamber and non-process drains are provided to allow re-cycling of the non-process condensate to be directed back to user’s house boiler system. 

A vacuum pump is provided as the means for air evacuation of the chamber. The vacuum pump is a close-coupled design utilizing a bronze impellar. 

A 0.2 um disposable vent filter is provided as standard for air admission into the chamber. A 0.2 um sterilizable-in-place insitu filter is available as an option. The option includes an independent sterilization cycle for the filter.

The filter is installed in a 316L stainless steel housing. Citric Acid passivation of the chamber and process piping can be provided as an option. 


Welding Documentation 

A weld certificate is provided a standard for all stainless steel orbital welding performed on the sterilizer. This certificate states that all welds have been performed in accordance with the Alfa Corporation welding procedure and that 100% of welds were inspected by borescope examination or by visual means. 

Weld Documentation of all process piping can be provided as an option. 

The documentation shall include: 

Video tape inspection of all welds 
Material certifications 
Weld Schedules 
Weld logs 
Weld Map 
Gas certificats 


Applicable Codes and Documents 

The Alfa Corporation cGMP Steam Sterilizer is designed to meet the following industry codes or internal Alfa procedures: 

FDA regulation 21 CFR, part 11 cGMP requirements 
AAMI / ISO 111345-R-8/93 Industry Standard for Moist heat Sterilization 
ASME Section VIII, Division I Unfired Pressure Vessel code 
National Electrical Code (NEC) 
National Plumbing Code 
Alfa Orbital Welding Procedure 
Alfa Final Test and Inspection Procedure 
Alfa Functional Requirement Specification 
Alfa Software Requirement Specification 


Material Handling Accessories 

Loading carts are constructed of 316L stainless steel. Two (2) shelves are provided as standard for each load cart. 

Transfer carriages are constructed of 304 stainless steel. Two (2) swivel and two (2) fixed casters with brakes are provided for wheels 

Racks with two (2) shelves, bottom shelves, and instrument trays are constructed of 316L stainless steel. 


Ancillary Equipment Available 

Air Compressors 
Electric Steam Generators 
Clean Steam Generators (steam to steam) 
Steam filters 
Service trolley for electric steam generators 


Quality Assurance Testing 

All Alfa cGMP Steam Sterilizers are tested to the Alfa Corporation Final Test and Inspection Procedure #SOP-001. The testing includes: instrument calibration to NIST standards, input and output check, leak test, high-potential test, alarms test, and consecutive execution of sterilization cycles to insure repeatability. Temperature control to within +/- 0.5 oC is verified for all sterilization cycles. A one (1) hour temperature distribution is performed using 16 thermocouples to verify chamber temperature uniformity meets or exceeds +/- 0.5 oC. Verification of all drawings vs actual equipment is performed. 


Documentation Provided 


Alfa Corp. cGMP Steam Sterilizer is provided with the following documentation package: 

Operator and Preventative Maintenance Manual 
Chamber U-1 form – ASME Section VIII, Division I certification 
As-built Fabrication Drawings: Equipment layout, Piping & Instrumentation Diagram, Electrical Diagram, Pneumatic Diagram 
Recommended Spare Parts List 
Warranty statement 
Orbital Welding Quality certificate 
Functional Requirement Specification 
Software Program Printout – PLC Ladder Logic 
Instrument Calibration certificates 
Calibration certificates of in-house calibration equipment 


Warranty 

The Alfa cGMP Steam Sterilizer is provided with a full one (1) year warranty for parts and labor. The chamber is provided with a warranty of 15 years. Contact Alfa Corporation for the terms and conditions of the warranty. 

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