The Process Challenge Device(PCD) packs are used to monitor steam sterilization loads and can be used to release non implant loads. The PCDs are designed for use in standard steam sterilizing processes, including 250° F (121°C) gravity steam, 270°F (132°) prevacuum
Each pack consists of a series of steam penetration and air removal barriers. A Class 5 integrator, as defined by EN ISO 11140-1, is located in the center of the barriers. The test pack is placed within the chamber of each load to be steam sterilized.
During processing, the sterilizer must remove or displace the air from the barrier material and replace it with steam throughout the pack. If a failure should occur, the indicator ink can assist in detecting steam quality issues based on the characteristics of the failure patterns of the indicator ink.
The Process Challenge Packs are manufactured in the absence of lead and heavy metals.
| Monitors the validated sterilization parameters required to be delivered |
| World recognized standard |
| Provides immediate identification of failed loads |
| Documentation of successful sterilization cycles |
| Early identification of indicator application |
| Traceability and recognition of expired packs at time of use |
| Failure pattern aids in identifying root cause of cycle failure |
| No concerns over lead exposure or the toxicity of other heavy metals |
| Monitors all critical parameters of steam sterilization (time, temperature and steam quality) |
| One integrator indicator compatible with most steam sterilization cycles |
| Endpoint comparison is clear and unambigious |
| No concern of the toxicity of lead or other heavy metals exposure |
| Features |
| |
| Class 5 integrator conforms to ANSI/AAMI/ISO 11140-1 |
| Abrupt /distinctive total color change from yellow to blue/purple |
| Test sheet may be kept as a permanent record |
| Large indication of temperature and time with color specific coding |
| Lot number and expiration date on each pack |
| Ink pattern can assist in identifying steam quality issues |
| Manufactured in the absence of lead and heavy metals |
Audited Supplier 
){kind=link}