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Quality Work Requires Quality
Equipment We
have both manufactured and sourced the highest quality validation and
test equipment to ensure that our validation work is of the highest
quality. We can also supply this equipment for your own in-house
validation teams.
Ampoule Holders
Self-contained
Biological Indicator ampoules are widely used in the validation of
fluids sterilisation processes and provide very reliable data as long as
they are used properly.
It is essential that the BI ampoule and the thermocouple tracing wire are securely
located at the slow-to-heat point in the liquid and that they remain in
that position throughout the cycle!
Our ampoule holders are purpose-designed for each application.
Machined from PTFE and using stainless steel spring wire to
retain the ampoule, they are suitable for use in most pharmaceutical
products and can be supplied to suit the ampoule types and fluids
container. The photographs show some of the applications we have
addressed - prices can be supplied upon request for specific customer
applications.
Please
Contact
us for Pricing Information
Complete
packs can be produced to cover your range of products and validation
requirements.
The pack shown on the left covers a range of vials and
bottles from 10ml to 500ml.
All ampoule holders can be supplied with a centre
hole for inserting a thermocouple adjacent to the ampoule, guaranteeing
that both ampoule and thermocouple remain in the liquid centre
throughout the cycle.
We also manufacture sets for unique
products such as blow-fill-seal bottles.
Thermocouple Wire
The correct
thermocouple wire is essential to ensure that temperatures in the
difficult parts of the load can be monitored. It is also essential that
the thermocouples do not affect air removal or steam penetration. The
type T Class 1 thermocouple wire that we use has a proven track record
in offering the most reliable solution.
Thermocouple Entry Gland
We use a very
high quality thermocouple entry gland suitable for sealing 72
thermocouples entry into the autoclave chamber, providing a secure,
non-damaging seal.
We developed this thermocouple entry gland for our
own purposes as the best way to seal thermocouples entering the
autoclave. The entry gland is available for a range of triclover
connections and other special connections such as the Fedegari-type
connections.
Load Temperature Probes
Load temperature
probes offer many advantages for the control of fluids cycles. If they
are to be used they need to be properly designed to ensure that they
provide accurate and representative data from the slow-to-heat point
within the fluids container and the load, and that they will survive the
operational environment.
We can design and supply the correct load probe
for your application. We can also temperature-map the fluids container
to provide the data to design the load probe.
Steam Quality Test Kits
The limits set
for Non-Condensable Gases, Dryness Value and Superheat in HTM 2010 are
based upon the use of this equipment and it is important that the
equipment is used as the standard directs. The formulae defined in
HTM 2010, particularly for the Dryness Value use constants which rely
upon the use of this equipment.
The test kits that we supply are the test kits
that we use. The kits are supplied with all necessary calibration
certificates and procedures for use. We can also deliver comprehensive
on-site training for the continued proper use of the Steam Quality Test
kits and the HTM 2010 methods.
Line Pickerill Helix
Used as an HTM 2010
standard benchmark test for Ethylene Oxide and LTSF sterilisers, these
devices have also been used as a benchmark test on autoclaves for other
applications.
Towels for HTM 2010 and EN 554 Benchmark
Testing
The benchmark test for porous
load autoclaves initially developed by Dr Bowie in 1963 has changed
little in the last four decades. The specification of the towels used
has changed over that period, but little else.
We can supply standard test packs to BS5815, as required by HTM 2010 and
EN 285. The towels are supplied in packs of
36.
Validation Toolkit
A toolkit that contains all of the specific
tools that a validation technician will require for work on the
validation of porous load and fluids autoclave cycles.
Arc Welder for making up Thermocouples on
site
For reliable thermocouple life
during validation studies a welded tip is recommended. This can easily
be achieved using an arc welder with an argon gas purge to provide the
best weld with minimum oxidation. This equipment can easily be used on
site to make up your own thermocouple looms or to repair existing
thermocouple looms.
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