TECHNICAL SHEET
TS 610335
Rev. 1 of 10.07.2009
Pag. 1 of 2
BUFFERED NaCl- PEPTONE SOLUTION pH 7.0 (acc. to Harmonized EP- ISO 21149)
Medium for the microbial examination of non-sterile pharmaceutical products according to European Pharmacopoeia.
TYPICAL FORMULA (g/L)
Peptone
Potassium Dihydrogen Phosphate
Disodium Hydrogen Phosphate dihydrate
Sodium Chloride
Final pH 7.0 ± 0.2
1.0
3.6
7.2
4.3
DESCRIPTION
BUFFERED NaCl- PEPTONE SOLUTION pH 7.0 (acc. to Harmonized EP- ISO 21149) is a medium for the microbial examination of non-sterile
pharmaceutical products, e.g. solution for sample preparation or dilution or washing solution, according to Harmonized European Pharmacopoeia.
PRINCIPLE
The low content of peptone as well as the content of phosphate buffer and sodium chloride maintains the viability of present microorganisms without
supporting growth.
PREPARATION
Suspend 16.1 g of powder in 1 liter of distilled or deionized water. Heat until completely dissolved. If necessary add 1-10 ml Tween 20 or 80 per litre of
culture medium. Dispense in final containers. Sterilize in autoclave at 121 °C for 15 minutes.
TECHNIQUE
Aseptically introduce the material to test in the container of the medium.
STORAGE
10-30°C away from light, until the expiry date on the label or until signs of deterioration or contamination are evident.
Store the prepared medium at 2-8 °C.
WARNING and PRECAUTIONS
The product is not classified as hazardous by current legislation and does not contain harmful substances in concentrations of ≥1%.
The product must be used only by properly trained operators.
DISPOSAL of WASTE
Disposal of waste must be carried out according to national and local regulations in force.
REFERENCES
1. European Pharmacopoeia 5.0 (2004) 2.6.13. Microbial Examination of non-sterile products.
2. International Harmonisation: (2003): Pharmeuropa 15, No. 3, July 2003: 563-573.
Liofilchem s.r.l.
Via Scozia, Zona industriale - 64026 Roseto degli Abruzzi (Te) Italy - Tel. +39.0858930745 - Fax +39.0858930330
Web site: http://www.liofilchem.net - E-mail: liofilchem@liofilchem.net
TECHNICAL SHEET
TS 610335
Rev. 1 of 10.07.2009
Pag. 2 of 2
PRODUCT SPECIFICATIONS
NAME
BUFFERED NaCl- PEPTONE SOLUTION pH 7.0 (acc. to Harmonized EP- ISO 21149)
PRESENTATION
Dehydrated medium
STORAGE
10-30 °C
PACKAGE
Code
Content
610335
500 g
Packaging
500 g of powder in plastic bottle
pH OF THE MEDIUM
7.0 ± 0.2
USE
BUFFERED NaCl- PEPTONE SOLUTION pH 7.0 (acc. to Harmonized EP- ISO 21149) is a medium for the microbial examination of non-sterile
pharmaceutical products, e.g. solution for sample preparation or dilution or washing solution, according to Harmonized European Pharmacopoeia.
TECHNIQUE
Refer to technical sheet of the product.
APPEARANCE OF THE MEDIUM
Dehydrated medium
Appearance: free-flowing, homogeneous.
Colour: light beige
Prepared medium
Appearance: clear
Colour: light amber
SHELFLIFE
4 years
QUALITY CONTROL
1. Control of general characteristics, label and print
2. Microbiological control: the buffer solution to be tested is inoculated with 100-1000 CFU/ mL. Directly after inoculation as well as after an
incubation time of 1 hour at 20 to 25 °C for each test strain, 100 µL are subcultured on Columbia Blood Agar. The viable count should not
change from the beginning to the end of incubation.
Microorganisms
Recovery
Staphylococcus aureus
ATCC 25923
No change of CFU
Escherichia coli
ATCC 25922
No change of CFU
Pseudomonas aeruginosa
ATCC 27853
No change of CFU
Bacillus subtilis
ATCC 6633
No change of CFU
Candida albicans
ATCC 10231
No change of CFU
TABLE OF SYMBOLS
Batch code
Temperature limitation
Manufacturer
Contains sufficient for <n>
tests
Catalogue number
Keep away from heat
Use by
Caution, consult
accompanying documents
Liofilchem s.r.l.
Via Scozia, Zona industriale - 64026 Roseto degli Abruzzi (Te) Italy - Tel. +39.0858930745 - Fax +39.0858930330
Web site: http://www.liofilchem.net - E-mail: liofilchem@liofilchem.net