User Manual

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Columbus, OH, 43228
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www.intertek.com
Survivor Filter Report No.:102092758COL-002
Date: June 12, 2015 Page 4 of 8
GFT-OP-10b (12 April 2013).
Benchmark and Non-Standard test Report: Report must be reproduced in its entirety
ii. Positive control: Serial dilution of the bacterial suspension will be performed
using PBS and aseptically processed using the membrane filter technique
5. Steps (b)1-3 are repeated for Survivor Filter Pro Model
II. V
iral Analysis
a. Challenge Suspension Preparation
1. Phi X174 (#124425) to be obtained from Carolina Biosciences
2. Sample to be enumerated via serial dilution to confirm concentration
3. A dilution of the stock suspension will be made so that the density of viral particles is
approximately 1 to 5x10
6
plaque forming units (PFU) per mL
b. Test Procedure
1. 100 mL of the challenge suspension is filtered through the Survivor unit
2. Samples will be serial diluted will be plated on nutrient agar utilizing the agar overlay
technique, inverted, and incubated at 36 ± 1 °C (97 ± 1 °F) for 24 h
i. Serial dilution plating will be performed in duplicate
3. Plates are to be enumerated after the incubation period and results expressed as the
number of PFU/mL
i. Only plates within the range of 20-300 PFU will be reported
4. Control Samples to be performed as follows:
i. Negative control: PBS will be filtered through unit and enumerated
ii. Positive control: Serial dilution of the viral suspension will be performed using
PBS and aseptically processed using the membrane filter technique
5. Steps (b)1-3 are repeated for Survivor Filter Pro Model
III. Chemical Analysis
a. Challenge Suspension Preparation
1. Plasma Water is obtained from Fisher Scientific (W9-2)
2. Pb/Hg/Cd standards at 50,000ppm shall be used.
3. 20mL of plasma water shall be doped with 10mL of Each Standard totaling 10000ppm
Pb/Hg/Cd in 50ml H20
b. Test Procedure
1. 50 mL of the challenge suspension is filtered through the Survivor unit
2. The filtered solution shall be analyzed via ICP-OES analysis as specified in IEC 62321
3. Control Samples will be performed as follows:
i. Negative Control: Sterile Plasma will be filtered through the unit prior to
testing and collected. This filtered plasma water will serve as a blank and
subtracted out of any testing results.
ii. Positive Control: The elemental suspension created in V will be diluted and
ran through the ICP-OES analysis to confirm concentration.
Parameters
A digital hygrometer will be used to ensure the temperature range stayed within that specified in the procedure
above.
Survivor Filter
Survivor Filter
Survivor Filter
Survivor Filter