DOC.SYS.059
Instrument Decontamination
revisie 05
Instrument Decontamination
1. Introduction
To the protection of our employees and representatives under EU Council Directive 89/391/EEC of 12 June 1989 and Council Directive 91/393/EEC of 27 June 1991, it is essential that all apparatus and/or components that CYCLERtest accept to perform work on are free of biologocal, chemical and/or radioactive contamination.

This procedure is to be used for instrumentation destined for return to CYCLERtest BV for repair, maintenance, calibration, warranty, trade-in or recycling purposes or for calibration of Thermal Cyclers at customer location (on-site).
2. Return of temperature measurement instrumentation (MTAS / DRIFTCON)
Potentially contaminated instrumentation cannot be approved for return from the field until it is certified as "clean". A complete decontamination must be performed on all instrumentation or parts suspected of being contaminated. The Certificate of Decontamination form should be used to certify the instrumentation and it’s parts as “clean” and that the required decontamination process has been completed.

The Certificate of Decontamination should be signed off and attached to the outside of the box in a "shipping docs" bag. European customers should fax the form to CYCLERtest BV and enclose a copy in the shipping box.

Under no circumstances will any returned instrumentation be approved or accepted for return without having the Certificate of Decontamination attached or enclosed. CYCLERtest BV cannot accept any instrumentation that may be contaminated with viable biological agents, harmful quantities of hazardous chemicals, or radioactive materials.
3. Thermal cyclers or Thermal instruments (Calibration at customer location)
Thermal cyclers must be decontaminated before a CYCLERtest technician will perform a calibration. Refer to your thermal cycler's operations manual or contact the thermal cycler supplier which decontamination procedure is suitable and appropriate for the instrument.

Potentially contaminated instrumentation cannot be approved for calibration by a technician until it is certified as "clean". A complete decontamination must be performed on all thermal cycler and parts suspected of being contaminated. The Certificate of Decontamination form should be used to certify the thermal cycler "clean" and that the required decontamination process has been completed.

The Certificate of Decontamination should be signed off and attached to the thermal cycler prior to any on-site calibration / validation of the instrument by CYCLERtest.

Under no circumstances a CYCLERtest technician will perform a calibration of any PCR instrumentation without having the Certificate of Decontamination attached and visible. CYCLERtest technicians will not accept any instrumentation that may be contaminated with viable biological agents, harmful quantities of hazardous chemicals, or radioactive materials.
CYCLERtest employees are not permitted to enter Biosafety Level/Containment Level 4 Laboratories
4. Decontamination procedure of CYCLERtest instrumentation
Applicable to CYCLERtest instrumentation:

MTAS systems
Hardware module, all probesets, fixtures and all parts (notebook, block covers etc.) which have been in contact (directly or indirectly) with contaminated instruments

DRIFTCON systems
Hardware module, all probesets, fixtures and all parts (block covers etc.) which have been in contact (directly or indirectly) with contaminated instruments
Do not submerge the MTAS / DRIFTCON parts in any liquid
Do not autoclave the MTAS / DRIFTCON parts
4.1. Decontamination of MTAS / DRIFTCON hardware
Excluding probe sets en probe fixtures
4.1.1. Biological Agents
Hazard Group 1 or 2
To decontaminate MTAS / DRIFTCON system hardware:
  1. Dampen a soft cloth with 70% ethanol
  2. Wipe the outside surfaces of the hardware. Avoid getting liquid onto the cable connection and communication ports
  3. Keep surfaces wet for at least 5 minutes, then wipe dry
  4. Repeat steps 2 and 3
  5. Clean all surfaces with a soft cloth to remove residual ethanol and wipe dry
Hazard Group 3 or 4
Contact CYCLERtest BV to determine the decontamination procedure
4.1.2. Radioactive Materials
See note 1

4.1.3. Hazardous Chemicals
Areas exposed to hazardous chemicals should be washed with ethanol or isopropanol

4.2. Decontamination of MTAS / DRIFTCON probe sets & probe fixtures ONLY
Do not submerge the sensors in bleach solution (or any liquid!). Do not disassemble the probesets / - fixtures
4.2.1. Biological Agents
Hazard Group 1 or 2
  1. Gently wipe the probe tips with a cotton swab that has been moistened with 70% ethanol
  2. Keep surfaces wet for at least 5 minutes, then wipe dry
  3. Repeat steps 1 and 2
  4. Clean the sensors with a soft cloth to remove residual ethanol and wipe dry
  5. Complete a Certificate of Decontamination
Hazard Group 3 or 4
Contact CYCLERtest BV to determine the decontamination procedure
4.2.2. Radioactive Materials
See note 1

4.2.3. Hazardous Chemicals
Sensors exposed to hazardous chemicals should be washed with ethanol or isopropanol alcohol

NOTE 1: Radioactive Materials
  1. Apply an industry standard radioactivity decontaminant to the instrument (use cotton swaps for sensors) and wipe the surfaces as directed by the contaminant manufacturer
  2. Survey the instrument with an appropriate radio-activity –measuring instrument
  3. Satisfactory decontamination is defined as survey results at or below background level