CERTIFICATE OF ANALYSIS
BPW SWAB
Lot Manufacturing date Shelf-life
290125SBPW 08-jan-2025 01 year
Sterilization method
Gamma irradiation
Physical characteristics Specification Results
pH (25°C) 7.0 ± 0.2 6.9
Visual appearance Sponge: yellow to orange-yellow, free of impurities, may Conform
contain dark spots.
Medium: liquid, light yellow to very clear, clear.
Microbiology analysis
Sterility tests
Incubation Specification Results
35±2°C for 24h Absence of microbial growth Conform
Growth promotion tests
Strain Inoculum Incubation Specification Results
Salmonella typhimurium ≤102 CFU Aerobic, 35±2°C Good growth Conform
ATCC 14028 for 18-24h
Escherichia coli ≤102 CFU Aerobic, 35±2°C Good growth Conform
ATCC 25922 for 18-24h
Conclusion
This lot was analyzed and satisfy all the product specifications; therefore, it was APPROVED for use.
bioBoaVista guarantees the quality of its products with sealed packages. The Instructions For Use are
displayed overleaf.
Approval: 15-jan-2025
Ludimila Alfredo
Quality Analyst
Document available on: www.bioboavista.com.br
A.L.B. Luz – 437 Um Street, Jd. Nova Espírito Santo, CEP 13273-200, Valinhos, São Paulo, Brazil
+55 (19) 3849-7499
[email protected]
www.bioboavista.com.br
TECHNICAL DATA SHEET Revision 3.0
BPW SWAB Precautions and special care
Product intended for in vitro diagnostic use only.
Presentation Restricted for use by professionals. Do not inhale or ingest.
Conical bottom plastic tube with screw cap and leak-proof rings Do not use the product beyond the expiration date, with signs of
containing 10ml and cap with sterile flocked nylon swab. contamination, or if it has changed color. In the presence of
contamination, the product should be immediately discarded.
Sterilization method Do not use the product if the packaging is damaged or tampered
Gamma irradiation. with.
Application Storage
Used as a dragging swab for environmental monitoring, Store between 2-35°C in a dry place and protect from light.
especially for collecting samples for the detection of Salmonella
spp. The presence of Buffered Peptone Water (BPW) ensures Shelf-life
non-selective pre-enrichment of microorganisms present in the 1 year from the date of manufacture.
collected samples, keeps the cells viable and promotes the
recovery of injured cells until the laboratory analysis. Disposal of the product
After use, the product must be handled at the generating unit
Principle before environmentally appropriate final disposal, in accordance
Non-selective enriched medium that allows the growth of with official regulations.
various microorganisms, particularly members of pathogenic
Enterobacteria such as Salmonella. It promotes the recovery of Quality Guarantee
injured cells by incubating the sample under non-selective bioBoaVista guarantees the quality of its products as long as they
conditions for at least 18 hours. are used according to their respective instructions and in
accordance with national and international references.
How to use bioBoaVista does not take responsibility for the use of its
Scrub the swab over the desired surface according to the products for purposes other than those described and approved
adopted sampling plan. At the end of the collection, place the by the company. All clinical diagnoses should be analyzed in
swab into the tube, break off the handle, and close the cap. Send conjunction with clinical evidence and not solely based on
the sample to the laboratory and proceed with the analysis laboratory results.
according to the adopted methodology.
References
Quality Control 1. Becton, Dickinson and Company. Difco & BBL Manual. Manual
Test Result of Microbiological Culture Media, 2nd ed., 2009.
2. ISO 6579-1:2017. Microbiology of food chain – Horizontal
Sterility Absence of microbial growth
method for the detection, enumeration and sorotyping of
Salmonella enterica Good growth with turbidity of
Salmonella. Part 1: Detection of Salmonella spp.
ATCC 14028 the medium
3. ISO 11133:2014. Microbiology of food, animal feed and water
Escherichia coli Good growth with turbidity of
- Preparation, production, storage and performance testing of
ATCC 25922 the medium
culture media.
Appearance Liquid medium, light yellow to
4. Manual de Métodos de Análise Microbiológica de Alimentos,
very clear, clear, may contain
Livraria Varela, 3ª ed., 2007.
slight precipitate
5. Merck Microbiology Manual. 12th ed.
pH at 25°C 7.0 ± 0.2
Results interpretation
Microbial growth is evidenced by the turbidity of the medium. If
growth is observed, perform microscopic analysis, subculture on
selective media, and biochemical tests to identify isolated genera
and species, if necessary. Perform the reading according to
official compendia or internal laboratory methodology.
A.L.B. Luz – 437 Um Street, Jd. Nova Espírito Santo, CEP 13273-200, Valinhos, São Paulo, Brazil
+55 (19) 3849-7499
[email protected]
www.bioboavista.com.br
