1. Documentation Labels & Labeler Gun
Proper clear marking and the possibility to trace packed instrument trays and containers is essential in case of re-calls but also for logistical and patient record keeping. All these data can be simply provided by a double (2) label line gun label with indicator. STERINTECH gives a double label as the top label can be used for documentation purpose in patient records.
The medical device directive is prescribing that all sterile medical devices should at least carry the following information:
- Lot Number
- Packaging date
- Expiry date
- Sterile / Non-sterile
Characteristics
- Process Indicators (Steam, EO, Form, Plasma) conforms to ISO 11140-1 class 1
- Clear transition of indicator into its end-color
- Easy to use label gun
- Double labels serve for an easy traceability and documentation
- - Non-toxic / Lead free indicators
STERINTECH offers a 2/ 3 line label which is used by various institutes as per their requirement and the amount of data required on each label. These label rolls are as per the below specifications.
| STERILIZER | VARIANT | GUN TYPE | REFERENCE CODE | PACKAGING |
| STEAM | 2 Line Indicator Label | Sterintech | 602.011.9000 | 750 Labels / roll |
| 3 Line Indicator Label | Monarch | 605.011.9000 | 750 Labels / roll | |
| 3 Line Indicator Label | Blitz | 606.010.7500 | 750 Labels / roll | |
| ETHYLENE OXIDE (EO) | 2 Line Indicator Label | Sterintech | 602.031.9000 | 750 Labels / roll |
| 3 Line Indicator Label | Monarch | 605.031.9000 | 750 Labels / roll | |
| 3 Line Indicator Label | Blitz | 606.030.7500 | 750 Labels / roll | |
| PLASMA | 2 Line Indicator Label | Sterintech | 602.030.9000 | 600 Labels / roll |
| 3 Line Indicator Label | Monarch | 605.021.9000 | 500 Labels / roll | |
| 3 Line Indicator Label | Blitz | 606.021.7500 | 500 Labels / roll | |
| FORM | 2 Line Indicator Label | Sterintech | 602.040.9000 | 750 Labels / roll |
| 3 Line Indicator Label | Monarch | 603.040.9000 | 500 Labels / roll | |
| 3 Line Indicator Label | Blitz | 605.040.9000 | 500 Labels / roll |
2. Autoclave/ EO/ Plasma Tapes
These tapes are adhesive tape used in autoclaving (heating under high pressure with steam to sterilise) to indicate whether a specific temperature has been reached. Autoclave tape works by changing color after exposure to temperatures commonly used in sterilization processes, typically 121°C in a steam autoclave.| STERILIZER | VARIANT | REFRENCE CODE | PACKAGING |
| STEAM/Autoclave | Autoclave 19mm x50m | 503.025.0001 | 1 |
| EO | EO 19mm x 50m | 503.025.0001 | 1 |
| PLASMA | Plasma 19mm x 50m | 504.025.0001 | 1 |
3. BOWIE DICK Test
Bowie- Dick Test pack was developed for testing whether steam sterilizer could effectively sterilize cotton / textile packs, whereas the Helix was developed especially to test whether inside instruments and tubes with narrow internal lumen steam sterilization was effective. Since 1963 the Bowie Dick Test Pack has become the one and only standard sterilizer test for hospitals. Still today there are countries which uses only Bowie Dick Test pack as a daily test regardless the actual loads they are sterilizing. But Since 2001 WFHSS world congress where experts in the field of validation and engineering of steam sterilizers were questioning the Bowie Dick test pack, then Helix device started to replace the Bowie Dick test pack more and more. These days Helix device as Bowie-Dick test has been adapted by International StandardsCharacteristics
- Bowie-Dick Test Pack is a disposable single use pack
- Bowie-Dick Test Sheets are single use sheets (comes in a pack of 50 sheets)
- Clear color change indicators
- Non- Lead / Non- Toxic
- Lot number on indicator sheet Indicator sheet can be kept in record for up to 10 years.
| STERILIZER | VARIANT | REFRENCE CODE | PACKAGING |
| STEAM | Bowie Dick Test Pack | 102.002.0020 | 1 Pack |
| Bowie Dick Test Sheet | 102.010.0050 | 50 Sheets / Pack | |
| Bowie Dick Helix Test (SS) Blue to Pink | 101.203.0100 | 500 strips & 1 Device / Pack | |
| Bowie Dick Helix Test (SS) Yellow to Black | 101.005.0500 | 500 Strips & 1 Device / Pack |
4. BATCH CONTROL / BATCH MONITORING
In these days the main category of products sterilized at the CSSD is consisting out of instrument trays and containers with instruments which are getting more and more complex by having narrow lumen inside the challenge for sterilization is to reach sterilization conditions even inside those complex instruments. Monitoring sterilization conditions inside pouches and containers by use of class 4, 5 and/or 6 indicator strips is practiced a lot in our markets but the batch monitoring by the use of Helix devices is recommended more and more by international and national institutes and governmental organizations. A Helix device has proven to detect sterilization problems earlier and as such enhances quality control at the sterilization department. Compared to the use of Biological indicators the Helix batch monitoring is easier and quicker in terms of interpretations. Batch Monitoring is advised by well-known international organizations like the Robert Koch Institute (Germany), the Dutch Ministry of Health (RIVM) as well as DGKH (German society of Hospitals).Few of the unique failure detection by Helix devices;
- Insufficient vacuum
- Insufficient air removal from hollow devices
- Insufficient steam penetration in hollow devices
- Leakages of piping / valves / seals
- Detection of presence of small volume inert gases
- Detection of excessive amounts of condensate
- Different load conditions
| STERILIZER | VARIANT | REFERENCE CODE | PACKAGING |
| STEAM | Batch Control Helix Test Yellow to Black | 103.005.0500 | 500 strips & 1 Device / Pack |
| Batch Control Helix Test Blue to Pink | 103.203.0100 | 500 strips & 1 Device / Pack | |
| ETHYLENE OXIDE (EO) | Batch Control Helix Test | 103.230.0100 | 500 strips & 1 Device / Pack |
| PLASMA | Batch Control Helix Test | 103.020.0100 | 500 strips & 1 Device / Pack |
| FORM | Batch Control Helix Test | 103.040.0100 | 500 strips & 1 Device / Pack |