Sterilization Validation Consumables
The Honeyman Group has been carrying out validation services for decades and our experience has led to a selective range of quality consumables, offering best value for money whilst meeting the stringent requirements in Pharmaceutical applications.
Available consumables from the Honeyman Group are:
- Bowie Dick Towels for HTM 2010 and EN 285 Benchmark Testing
- Steam Quality Test Kits
- Ampoule Holders
- Thermocouple Wire
- Thermocouple Entry Gland
- Load Temperature Probes
- Line Pickerill Helix
Bowie Dick Towels for HTM 2010 and EN 285 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.
Steam Quality Test Kits
The limits set for Non-Condensable Gases, Dryness Value and Superheat in HTM2010 and more recently EN 285 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 these standards, 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 clean steam quality test kits and the methods described in the standards.
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.
Mixed packs can be produced to cover your range of products and validation requirements.
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 can also manufacture bespoke sets for unique products such as blow-fill-seal bottles.
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.
Developed by our own team of validation professionals, our thermocouple entry gland has proven 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 Fedegari 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.
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.
For more information and for a quotation please contact us.