PHARMACEUTICAL MICROBIOLOGY ANALYSIS REQUEST FORM
Testing Requirements
Company Details
Company Name
:
ILS Account Code
:
Contact Name
:
Telephone No.
:
PO Number
:
Date
:
Sterility Testing
Membrane Filtration
Direct Inoculation
Direct Inoculation with Transfer
Sterility Method Validation Required
Preservative Efficacy Testing
Sample Details
ILS Suite Code
EP
USP
EP & USP
4 Organisms
5 Organisms
6 Organisms
Topical/Parenteral/Opthalmic product
Oral product
Oral with high sugar product
Microbial Contamination Testing
Additional Required Sample Information
Out of Stock Medicinal Products
Time Critical Samples
Short Shelf Life Medicinal Produces
None of the above
NB Please contact ILS for samples that may be deemed critical for reasons
not identified above
Sample Details
ILS Suite Code
Additional Required Sample Information
Out of Stock Medicinal Products
Time Critical Samples
Short Shelf Life Medicinal Produces
None of the above
Total Yeast & Mould Count
Spec:___________cfu/
Total Aerobic Microbial Count Spec:___________cfu/
Bile Tolerant Gram Negative Bacteria
cfu/g (MPN)
Absent in 1g
E. coli
-Absent in 1g
S. aureus
-Absent in 1g
P. aeruginosa
-Absent in 1g
Salmonella
-Absent in 10g
C. albicans
-Absent in 1g
Clostridia
-Absent in 1g
Microbial Contamination Method Validation Required
Herbal Medicinal Product Contamination Testing
NB Please contact ILS for samples that may be deemed critical for reasons
Table A
Table B
Table C
Herbal Contamination Method Validation Required
Endotoxin Testing
not identified above
Sample Details
ILS Suite Code
Additional Required Sample Information
Gel-Clot test
Limit:
Turbidimetric test
Limit:
Endotoxin Validation Required
Eu/
Eu/
Environmental Monitoring
Out of Stock Medicinal Products
Time Critical Samples
Short Shelf Life Medicinal Produces
None of the above
TSA Settle (90mm)
TSA Contact (55mm)
NB Please contact ILS for samples that may be deemed critical for reasons
SDA Settle (90mm)
SDA Contact (55mm)
Bioburden (Medical Devices) Testing
Test
No. of samples:
Bioburden Method Validation Required
not identified above
Sample Storage Conditions
Water Testing
Ambient
2 - 8°C
-20°C
Reporting Requirements
Portrait Report
Landscape Report
Single Sample
Multi - Sample
Email:
Pdf Report only
Pdf & Posted Report
TVC 22°C
TVC 37°C
Coliforms
E. coli
S. aureus
P. aeruginosa
Purified in bulk
Purified in containers
Pseudomonas spp.
Enterococci
Salmonella
Clostridium spp.
Clostridium perfringens
Legionella spp.
Sterilised WFI
WFI in bulk
N.B. – Sample submission by client will be taken as ILS Standard Terms and Conditions are accepted (Available on request).