Thanks for the replies.
I think I need to qualify my question a little by attaching the related section from PS9000:2011 pharmaceutical packaging standard.
ps9000.gif 57.55KB
101 downloads
What sort of processes, procedures, documentation would be expected in this area? Especially in section H on machines and lines.
Thanks,
Simon
As for as documented risk assessment is concerned, it varies from equipment to equipment & plant to plant. eg risk assessment of a liquide process will be different from that of dry powder particulate. Any how you need to conduct the following assessments:
Mechanical components verification
Pre-shipment inspection and testing of equipment, conducted at vendor site.
• Inspection of equipment upon arrival at the plant.
• Inspection of equipment installation, verifying proper installation versus
design.
• Testing of equipment, verifying equipment operation versus specification.
• Testing during processing, which includes testing the interaction of equipment
and process control with water or other media to ensure controls, interlocks,
and processes operate as designed.
• Calibration and verification of maintenance, which includes:
− Calibration of critical instruments and proper functioning of interlocks.
− Verification that disposable and removable equipment (e.g., filters,
screens, cartridges, magnets, equipment parts, etc.) are properly installed.
• Implementation of plant trials, conducted as needed to determine that rated
line speeds can be achieved and that the product can be produced as
designed.
Equipment design assessment may include questions like
Are there dead legs in the facility processing and filling equipment design?
Are sanitary valves, fittings and sampling valves installed? What is the capability of the CIP system
Are all equipment and utensils constructed to be free of corrosion, made of non-toxic materials, and
cleanable? Are the seams in the food contact surfaces smooth and free of cracks or crevices?
Are the food contact surfaces
of the equipment corrosion
resistant and rust free when
in contact with foods? Are
they able to withstand the
environment in which they
are used?
Is filtration used? List type,
size and location of filters?
Are magnets or metal
detection in place?
What type of filler(s) is being used at the
facility? List make and model.
What is the speed of the filler(s)
(packages/hour)?
What type of container is the filler
capable of filling? List the package types
and volumes.
Is the filler a gravity, counter pressure,
manifold type, bowl type, etc.?
Does the thermal process
system divert for low
pasteurization temperature
(measured at the end of the
hold tube)?
Ensure that the pasteurization
temperature is being measured at the
end of the hold tube. Ask what the
minimum pasteurization temperature is
and what the process step is if the
temperature falls below the minimum
setpoint.
Is the hold tube (hold time)
designed to maintain the
proper hold time for the
beverages processed?
Request to see the thermal process
document for the beverages processed
on the pasteurizer and compare the
requirements to the hold tube design.
Are the pressure differentials
throughout the pasteurizer,
trim cooler and other heat
exchanger systems
maintained in a positive
manner (sterile to non-sterile)
and documented for each
run?
Need to be 0.2 bar minimum
with electronic gauges, 0.35
bar minimum with
manual gauges or alternatively, have
air-gap safety heat exchanger
plates.
Request to see a P&ID for the
pasteurizer. Verify that the pasteurizer is
designed so that the pressure
differentials throughout the pasteurizer,
trim cooler and other heat exchanger
systems are maintained in a positive
manner (sterile to non-sterile). Review
the production records for three random
lots and verify that the differential
pressures are recorded and do not fall
below the minimum setpoints.
1.4
When any changes in the
thermal process parameters
have been made, has either;
• Re-qualification, or
• The change been
authorized by the
Support Center?
Verify that the facility has a change
management program. Request and
review the procedure for thermal process
parameters changes. Ask whether there
have been any changes to the
parameters since the installation of the
equipment. If so, request to review the
supporting documentation and verify that
the procedures were followed.
What are the make, model and type of
aseptic filler(s) used to sterilize
packaging material?
What types of containers and container
sizes were reviewed during the audit?
How is heat applied for container
sterilization?
Are the equipment sterilization critical
control points alarmed? List the
procedures if an alarm is triggered.
Are the packaging material sterilization
critical control points alarmed? List the
procedures if an alarm is triggered.
Are all regulating and recording controls,
thermometers, and other temperature
measuring devices installed and annually
calibrated on equipment? List calibration
schedules.
Was ongoing maintenance of regulating
and recording controls, thermometers,
and other temperature measuring
devices performed? Was the proper
documentation maintained and readily
available? List maintenance schedules.
Obtain and review the preventative maintenance
procedures and the supporting documentation to
demonstrate that the devices were maintained
according to schedule.
Are there procedures for assuring high
microbiological quality of packaging
materials both received and used?
Briefly describe the procedures.
Are there procedures for testing
hydrogen peroxide residual on packaging
material? Briefly describe the
procedures.
Other question regarding plant performance can also be added as per needs of equipment and filling line.
