Similac® Probiotic Tri-Blend Manufacturing and Quality Information

Strain Characteristics and Safety Specifications

Similac Probiotic Tri-Blend safety specifications support a probiotic suitable for hospital use.

 

B lactis BB-12®
B infantis Bb-02
S thermophilus TH-4®

Strain Bank Code

DSM 15954

DSM 33361

DSM 15957

Scientific Publications

425

9

19

Clinical Publications

217

6

9

Regulatory (Safety)

Species Level: EFSA Qualified
Presumption of Safety (QPS)

GRAS–US FDA (GRN No. 49)

Species Level: EFSA Qualified
Presumption of Safety (QPS)

Species Level: EFSA Qualified
Presumption of Safety (QPS)
GRAS–US FDA (GRN No. 49)

Genome Sequenced

Yes

Yes

Yes

Plasmids

None

None

Yes (Sequenced and Safe)

Antibiotic Resistance

Tet(W) — Nontransferable

None

None

Virulence Genes

None

None

None

Lactate Metabolite (L/D)

L

L

L

  • GRAS designation by the FDA is only required for food, including infant formula.
  • All 3 strains in Similac Probiotic Tri-Blend have been completely sequenced. Genome sequencing provides the most comprehensive understanding of the characteristics and functionality of the strains.
  • None of the 3 strains contain virulence genes, which means they lack any known genes associated with infectivity.
  • Similac Probiotic Tri-Blend strains do not have plasmids that contain transferrable antibiotic resistance genes and do not produce D-lactate per ESPGHAN probiotic guideline recommendations.

Microbial Contaminant and Manufacturing Specifications

Similac Probiotic Tri-Blend undergoes rigorous, multiphase microbiological contaminant testing.

At multiple stages, the materials, individual strains, and finished product (bulk and packaged forms) are tested for the following pathogens and hygiene indicators:

 

Safety/Purity

 Carrier (Maltodextrin) 
 Pre-Freeze Dried (Each Strain) 
 Freeze Dried (Each Strain) 
 Tri-Blend (Bulk) 
 Finished - Sachet 

Bacillus cereus (EFU/g)

Cronobacter spp. (E sakazakii)

Enterobacteriaceae

-

-

-

Listeria monocytogenes

Salmonella spp.

Staphylococcus aureus (CFU/g)

Sulfite reducing clostridia (CFU/g)

-

-

-

-

Total aerobic count (CFU/g)

Total yeast and molds (CFU/g)

  • Similac Probiotic Tri-Blend is manufactured according to cGMP (Current Good Manufacturing Practices) to help ensure correct strain identity and lack of contamination per ESPGHAN probiotic guidelines recommendation.
  • Similac Probiotic Tri-Blend manufacturing standards exceed industry standards.

Packaging and Shipping

Similac Probiotic Tri-Blend is shipped using a packaging system designed to maintain the integrity of the probiotics, which is crucial during climate fluctuations in shipment. The cold chain shipping system is designed to ensure that the probiotics are maintained at or below 25°C (77°F) until the product reaches its destination.

To inspect safety of the packaging, Abbott conducts package integrity assessments. This testing assesses the single-dose packaging for protection against the introduction of harmful contaminants from packaging through transit.

  • All packaging from sachet to carton to shipping containers comply with all food contact regulations and restricted substance regulations. Additionally, Abbott has developed its own list of “Abbott discouraged use” materials based on the latest food safety research and ensures compliance for all packaging.
  • Abbott performed additional migration testing to confirm packaging guards against introduction of harmful materials into the product from the packaging over time. This is not a requirement in the US or Canada where the product is distributed.

 

Labeling

The design and development of Similac Probiotic Tri-Blend has met all labeling guidelines set by the International Probiotics Association (IPA) “Best Practice Guidelines for Probiotics.”

  • The quantitative amount(s) of probiotics are expressed in Colony Forming Units (CFUs).
  • The labeled quantity of probiotics reflects the quantity of live microorganisms at the end of the stated shelf life, not at the time of manufacture.
  • The label identifies the genus, species, and strain for each microorganism in the product.
  • The labeled quantity of probiotics declares the total count of the blend in CFUs.

The ESPGHAN Working Group for Probiotics and Prebiotics strongly suggests a stringent quality control process that ensures the probiotic content as written on the label meets the actual content throughout the shelf life of the product, while no contamination is present. The quality control measures in place for Similac Probiotic Tri-Blend help ensure that the probiotic content stated on the label is delivered with no contamination present.

Manufacturing Standards

  • Qualified production equipment and software
  • Cleaning validation of all processes, to ensure safe and clean products
  • Independent Quality Assurance review and release of all batches
  • Equipment and environment is qualified for production of infant formula ingredients
  • Analytical methods for product release are validated to help ensure results