GMP
Pharmaceutical Autoclave
|
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.
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.
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
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.
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:
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.
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.
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:
The
Alfa Corporation cGMP Steam Sterilizer is designed
to meet the following industry codes or internal Alfa procedures:
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
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.
Alfa
Corp. cGMP Steam Sterilizer is provided with the
following documentation package:
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.