BIOLOGICAL INDICATOR  

CERTIFICATE OF ANALYSIS  

Reorder No. SBP/6

Bacillus pumilus                                  ATCC 27142

For:        Radiation Sterilization.

Culture:  Soybean casein digest broth.

Storage: Controlled room temperature. Store away from sterilants. Do not
              desiccate.

Disposal: Incinerate or autoclave at 121°C for not less than 30 minutes.

Purity：   No evidence of contaminants using standard plate count  
               techniques.

Lot No.:   BPUM-213P

Manufacture Date: 2001 JULY 26

Expiration: 24 months from Manufacture Date.

Heat Shocked Population:    1.7 x 10⁶ Spores/Unit

Assayed Resistance:

                              D-value⁽¹⁾

Radiation (CO⁶⁰)         1.2        kGy

D-value reproducible only when exposed and cultured under the exact conditions used to obtain results reported here. MPN and Survivor Curve methods used.

Units are manufactured In compliance with SGM Biotech's quality standards.

⁽¹⁾ D-value calculated using the Spearman-Karber method.

Biological Indicators for demonstrating adequate sterilization.  

INSTRUCTIONS

Sterilization

1. Place spore strips inside representative materials to be sterilized. Package or wrap as usual.

2. Identify test packages as to location. Locate test packages randomly within tote boxes entering radiation cell. Alternatively, place at demonstrated point of lowest absorbed dose.

3. After sterilizing, forward sufficient spore strips and products to sterility test laboratory along with at least one non-sterilized spore strip marked POSITIVE CONTROL.

Sterility Test Laboratory

1. All sterility testing should be performed in a clean, dust-free room - and within confines of a laminar flow hood. Personnel within the test area should be garbed in sterile gowns, masks, hoods, gloves, and boots. All transfers and manipulations must be conducted with rigid aseptic techniques to avoid "false positive" samples.

2. Procedure:

a.   Aseptically open glassine envelopes, withdraw spore strips with sterile forceps and
     transfer to individual tubes containing 10-15 ml sterile soybean casein digest broth.
     Identify tubes.

b.   Incubate spore strips 7 days at appropriate temperature.

Radiation .............B. pumtlus          30-35°C

c.   Observe tubes daily for growth.        Turbid = growth = non-sterile
                                               Clear = no growth = sterile

Test Strip cultures should show no growth if sterilization has been achieved. If turbidity

and bacterial growth occur in test strip cultures, it suggests that the spores have survived the sterilization process and are non-sterile.

3. Controls

a.   Positive: One or more positive controls should be included in each test series.
     Transfer a non-sterilized spore strip to culture medium and Incubate with test series.
      Turbidity and growth Indicates that the medium possesses suitable growth
     promoting qualities and that the spore strips contain viable spores. If positive control
      does not grow, do not use the lot.

b.   Negative: One or two tubes of culture medium incubated with test series. Absence
     of growth Indicates that the medium was sterile prior to sterility testing.