Sterility Assurance Testing

Sterility testing is a critical requirement in the manufacture of sterile pharmaceuticals and medical devices.  Sterility testing media must undergo growth promotion testing using prescribed microbial strains (USP <71>, EP 2.6.1, JPXV 4.06), and sterility testing methods must be validated (i.e. method suitability test) to assure their capacity to recover compendial strains when present in very low numbers (USP <1227>, EP 2.6.1, JPXV General Information section 30).  Alternative or rapid microbiological methods (RMMs) also require validation to verify equivalency with traditional sterility testing methods (USP <1223>, EP 5.1.6).  For these purposes, use of very reliable and consistent inocula is essential to eliminate variation attributable to factors other than the performance of the media, processes or systems being tested.  BioBall SingleShot and MulitShot 550 strains are certified reference materials with ISO Guide 34 certification, delivering the exceptional accuracy and precision required for growth promotion testing and validation studies.

 

Organism

BioBall Strain

Equivalent Strain

Cell or Spore

Reference 10 vials

Reference 20 vials® Strain

Aspergillus brasiliensis

NCPF 2275

CIP1431.83, IMI149007, NBRC9455,WDCM00053

Spore

56001

56011

Bacillus subtilis subsp. spizizenii

NCTC 10400

CIP52.62, NCIMB8054, NBRC3134

Spore

56002

56012

Candida albicans

NCPF 3179

CIP48.72, NBRC1594, WDCM00054

Cell

56003

56013

Clostridium sporogenes

NCTC 12935

NBRC14293, NCIMB12343,CIP100651, DSM1446

Spore

56004

56014

Kocuria rhizophila***

NCTC 8340

Cell

413835

412690

Pseudomonas aeruginosa

NCTC 12924

NCIMB8626, CIP82.118, NBRC13275,WDCM00026

Cell

56007

56017

Staphylococcus aureus

NCTC 10788

CIP4.83, NCIMB9518, NBRC13276,FDA209, WDCM00032

Cell

56009

56019

Staphylococcus epidermidis**

NCTC 6513

Cell

413809

56092

Streptococcus pyogenes

NCTC 12696

CIP104226

Cell

413820

56046

Re-Hydration Fluid

N/A

56021

14 Day Re-Hydration Fluid

N/A

410386

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Increasingly, sterility testing is applicable to cells and tissues, including cell and tissue therapies, blood products, and other biopharmaceuticals (EP 2.6.27).  These advanced therapeutics sometimes have the potential to be contaminated with more diverse micro-organisms because of their origin or handling, and are often tested by alternative or rapid methods due to their instability or a requirement for their immediate use.  Nevertheless, alternative and rapid sterility test methods must be validated against traditional sterility tests.  A wider array of strains might be appropriate for growth promotion testing and validation in these circumstances, but the need for exceptional accuracy and precision of the inocula remains.  The range of BioBall strains with potential application in sterility testing of cell and tissue therapeutics is growing.