STERI-BUFFER Details
Description
VAI® manufactures two sterile, disposable, sodium phosphate buffer solutions, STERI-BUFFER® 90 & 99, that are assayed to current USP Standards (Bufferfield’s Buffer) and buffered to a pH of 7.2 ± 0.2. STERI-BUFFER Products are available in either a 90 mL or 99 mL fill level.
STERI-BUFFER Products are processed to comply with the standards required by pharmaceutical, biotechnology, and medical device industries. STERI-BUFFER Products have been developed for use as a buffer solution and diluent in lab testing such a bioburden testing, pharmaceutical microbial limits testing, and AET testing and as a rinsing agent.
Patents: www.sterile.com/patents
Products:
STERI-BUFFER
Size
STERILITY
PRODUCT #
Options
90 Milliliter
Sterile
SB100-90
Easy To Twist Cap
99 Milliliter
Sterile
SB100-99
Easy To Twist Cap
-
Quality and Manufacturing
- Filled in an ISO 7 cleanroom (Grade B)
- Filtered at 0.2 microns
- Formulated with USP Water for Injection (0.25 EU/mL)
- Components are air washed with 0.2 micron filtered air before assembly
- Gamma irradiated at a 10-6 SAL
- Lot sterility tested according to current USP compendium
- Completely traceable from start to finish
- Completely validated for sterility and shelf life
-
Features and Benefits
- • Each sterile container is bagged two per bag in easy tear bags and packaged in two case liners for easy transport to the core
- Individually labeled with lot number and expiration
- Delivered with lot specific analytical, irradiation, and sterility data, tested to current USP compendium
- Available in two fill levels, 90 mL or 99 mL to fit your operation’s needs
- Assayed to current USP Standards (Butterfield’s Buffer)
- Buffered to a pH of 7.2 ± 0.2
- Each bottle has a “no tamper strip” that breaks once the bottle has been opened
- Disposable
- Odorless
-
Product Uses
- Rinsing agent
- Buffer solution in laboratory testing including bioburden testing, pharmaceutical microbial limits testing, and AET testing
Technical Documents
-
STERI-BUFFER-SB258.pdfSDS/SB258PDF
-
STERI-BUFFER-90-99-SDS-2002-SB9099-01-North-America-English-NAE-v3.1.pdfSDS/SB258PDF
Translations available in the following languages: -
STERI-BUFFER_9099_TDF_28Sep2017.pdfTechnical ReportsPDF