Testing & Validation

Success by Quality, Integrity, and Creativity is the motto we live by! At BIoCI, we believe that true customer satisfaction can only be obtained by the delivery of reliable, innovative products and highest quality services to our customers in a timely manner. We take quality seriously! BIoCI is not only in full compliance with the FDA's cGMP (QSR) for medical devices, it also became ISO 9001 registered within its first year of operation. Our strict adherence to these standards is our way of demonstrating our quality commitment to our customers, our partners, our regulators, and ourselves.


Brief Company Description

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Biological indicator (BI / SCBI) Population Assay
(ISO - 4 samples minimum, USP – 3 samples minimum)

BP-1

Single species

3 samples

Heat-shocked only

Heat-shocked & non-heat shocked

Additional sample

BP-2

Dual species

3 samples

Heat-shocked only

Heat-shocked & non-heat shocked

Additional sample

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Organism Identification /Verification
(per isolation / specie)

ID-1

colony morphology on given media, Gram stain.

ID-2

microscopic morphology characteristics

ID-3

biochemical profiling to the specie level

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Biological indicator (BI / SCBI) D-value Verification / Study
Note: Unless the mean population of samples is provided by client for D-value calculation, initial population assay is required.

BD-1

MPN method, USP (10 samples per exposure).

Note: more than 4 exposures may be necessary.

4 exposures minimum:

1 survival, 1 kill, at least 2 FPN cycles

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)

Additional exposure cycle

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)

BD-2

MPN method, ISO (20 samples per exposure).

Note: more than 4 exposures may be necessary.

4 exposures minimum:

1 survival, 1 kill, at least 2 FPN cycles

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)

Additional exposure cycle

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)

BD-3

Survival curve method (direct enumeration)

Note: more than 4 exposures may be necessary.

4 exposures minimum:

4 samples per exposure

(ISO, EN recommendation)

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)

Additional exposure cycle,

4 samples per exposure

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)

BD-4

Survival curve method (direct enumeration)

Note: more than 4 exposures may be necessary.

3 exposure minimum,

3 samples per exposure

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)

Additional exposure cycle,

3 samples per exposure

Steam (BIER)

Ethylene oxide (BIER)

Dry heat (oven)