SA Labs develops and executes Medical Device Sterilization Validations as a service to medical device manufacturers and hospitals, including Ethylene Oxide Sterilization Validations, Radiation Sterilization Validations and Steam Sterilization Validations. As an adjunct to those processes, we offer an array of associated microbiological testing services including both BI and product sterility testing, bacteriostasis/fungistasis testing and quantitative bioburden assessments of medical devices and pharmaceuticals.

Analytical chemistry capabilities supporting medical device sterilization include ethylene oxide residuals testing of sterile devices, including both EO and ECH and also LAL based analyses of residual endotoxins in water, pharmaceuticals and extracts from sterile devices.

• by providing  product and BI sterility testing for EO and steam sterilization validations
• quantitative bioburden testing and dose verification sterility testing for a radiation validation

Please contact us directly for a free consultation  regarding your validation requirements, or for a quotation specific to your particular sterilization validation.

Above: Validation load pallet being placed into an EO chamber

Below: Cobalt-60 gamma irradiation source rack in storage position 
Blue light is Cherenkov radiation.

Sterility testing services for products or product sample-item-portions are available to support the execution of both Radiation Validation Protocols and regular Dose Audits.

All bioburden determinations are conducted in accordance with the procedures and practices of ANSI/AAMI/ISO 11737. Options for the determination of  bioburden include aerobic bacteria, anaerobic bacteria, spores and fungi, or any combination thereof including all.

Microbial characterization of the bioburden, for recovered pure colonies is also available.

• The first phase is a series of preparatory tests demonstrating that the Method is appropriate for use with the item(s) to be tested and that those items will not be inhibitory to microbiological growth.
• The second phase, specific to USP <61>, is a  microbial enumeration test quantifying any aerobic bacteria, mold and yeast  that may be present in the sample.
• The third phase, conducted according to USP <62>, is a series of tests intended to screen the sample for specific microorganisms which typically include S. aureus, P. aeruginosa, E. coli, S. enterica and C. albicans, with C. sporogenes included as a representative anaerobe.

If an acceptance criterion is specified in a monograph, then microbial limits are provided.

Above: Microbial limits sample membrane filter after incubation with fluorescent imaging, ready for enumeration

Currently those requirements are:

1. a total viable plate count of < 200 cfu/mL for both dialysis water and conventional dialysate, with an action level of 50 cfu/mL for each (AAMI RD62:2006 and RD52:2004 rev. 2009)
2. a residual endotoxin  concentration of < 2 endotoxinunits (EU)/mL with an action level of 1 EU/mL, for each

For dialysate and dialysis water testing, SA Labs utilizes the membrane filtration technique for the capture of viable bacteria, with heterotrophic plate counts after culture on TSA, which is the de-facto reference method as specified in both AAMI RD62 and RD52, and the Limulus Amebocyte Lysate (LAL) Reagent technique for the determination of residual endotoxins.

Clients can also access their dialysis water testing results utilizing our internet based remote access database which includes continuous updates of the historical trends of the results for each client.

For clients located within the State of Arizona, SA Labs also offers a  courier pick-up service that allows for the delivery of the refrigerated samples to our facility in Tucson within 12 hours of sampling, a critical parameter for ensuring the most representative  results for the client’s process.

Analyses based on device sample item portions (SIPs), as determined on the basis of mass or area,  are a frequently requested option for Ethylene Oxide Residuals analyses.

Shown above: SAL Chromatography Lab

Insightful method development, diligent sample preparation, and a rigorous validation enables SA Labs to determine BOTH EO and ECH ethylene oxide residuals from a single extract of the sample.

Shown below: A chromatogram of the extract from a surgical sponge into water
The methanol peak is residual from the purge used to flush the auto-sampler syringe between samples.

Temperature and relative humidity calibration services are performed in our Thunder Scientific Humidity Generator.  This instrument provides some of the most accurate simultaneous temperatures (± 0.05°C) and relative humidity (± 0.4%) of any reference device.  An SA Labs official Certificate of Calibration is provided for all calibration services upon completion, listing “as received” and “as calibrated” data according to the client’s specifications.

We can calibrate most brands of self-contained temperature, relative humidity and pressure dataloggers in addition to most thermocouples, RTDs, thermistors and recording hygrometers, including those made by Datatrace®, Dickson®, Omega® and Fluke®.

Above: Some of the older Datatrace® FRB7200 style dataloggers are being readied for a datalogger calibration run in SA Labs Thunder Scientific Temperature-Humidity generator.

Below: Two of the newer Datatrace® M3H units are being readied for datalogger calibration.

Depicted above: a Dickson® THDx recording hygrometer is being readied for hygrometer calibration.