"Promoting the Science of Sterilisation"

New Generation Compact Helix-PCD
Batch Monitoring System

Despite validation of the sterilising process with the daily Bowie Dick test, routine monitoring should also be carried out on every cycle to ensure that all parameters have been met to enable the release of the load as sterile.

"Parametric Release" is declaring the product as sterile based on physical and/or chemical process data rather than on the basis of sample testing or biological indicators results (reference AS/NZ 4187 page 12).

Depending on local regulations, all steam sterilisation processes have to be validated annually and regularly checked with biological indicators, especially after start up and repair of equipment.

However for daily routine monitoring biological indicators are not practical due to their long response time.

Class 2 Chemical Indicators used inside the PCD can monitor the internal services of hollow MIS instruments etc to ensure that correct sterilisation has been achieved with the advantage of having the results of the sterilisation process available immediately. (NB For Pass/Fail information refer to  link on left hand side).

Sterilisation processes are designed to sterilise all goods successfully to achieve the required Sterility Assurance level of 10^-6 (Reference EN 556)  For example steam, temperature, time .

The Process Challenge Device (BMS) reference ISO 17665-1 (Sterilisation of Healthcare Products - moist heat) page 7, item 3.4 "the PCD is an item designed to contribute a defined resistance to a sterilisation process and is used to assess performance of the process".

Scientific tests have shown that hollow tubes and lumens are difficult to effect air removal and steam penetration and have a tendency to collect non-condensable gases inside the lumen or MIS instruments. 

 

 

 

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Physical data produced on the steriliser printout or pontentometer only recognises time, temperature and pressure, however they cannot recognise the presence of air or non condensable gases which can be entrained in the steam, if this occurs the inner surface of the above Trocar and other complex hollow instruments will not have a Sterility Assurance Level (SAL). 

The gke Batch Monitoring System is validated to EN 867-5 (Process Challenge Devices) and is designed to compliment the Bowie Dick test which is used every morning as a 'start up'. 

An air detector if fitted or Thermo-couples can only recognise air in the free space of the chamber and are unable to detect air in any hollow instrument inside a pack, therefore the need to monitor this aspect of the cycle is critical if we are to achieve sterilisation of hollow and/or complex instruments.

The chemical test strips may be adhered to documentation sheets in order to prove validation of every cycle.  (link to pass/fail on left)

Why use the Batch Monitoring System?

• Even if the Bowie Dick test has been successful, it is possible that the process parameters can change with each subsequent cycle. 

• Every delivery of steam to the steriliser can and will have different characteristics that will change in every cycle. 

• Insufficient vacuum, leaks in the steriliser or non condensable gases in steam may cause trapped air pockets inside packs, hollow devices and porous loads.

• Non condensable gases are the cause of most sterilisation malfunctions.

• The documentation of physical data such as pressure/temperature versus time cannot detect those malfunctions.

• The device is validated by an independent testing authority.

• The device consists of external durable plastic casing with a stainless steel coil inside. 

• The device can be used for an unlimited number of cycles.

• See link to Manufacturer's Directions for Use for more information

 

1st Generation Helix-PCD