Sampling Precautions

Before taking the sample, wear the following:

i. Heat-resistant gloves ii. Safety goggles

Annexure A

Sampling and Testing Plan

Rinses

Testing

Identification

Sample

Testing

Method/

S. No.

Test

Labeling

Volume (mL)

Sampling Bottle

Specifications

Procedure No.

l

pH

Rl-R6

lGG

Clean bottle

5-7 pH unit

STM-PL-001

2

Conductivity

Clean bottle

NMT 1.1 jas/cm

S

TOC

Clean bottle

NMT 500 ppb

S0P-QC-002

4

Biological product

Clean bottle

Not detected/less than the limit of detection (2.77 jag)

Validated HPLC method

5

Bio-burden

R7

lGG

Sterilized bottle

NMT 10 cfu/100 mL

STM-MC-001

6

Endotoxin

RS

lGG

De-pyrogenated bottle

0.25 EU/mL

MC-002

R1: filling needle 1, R2: filling needle 2, R3: filling needle 3, R4: filling needle 4, R5: postfilter, R6: rubber, R7: bio-burden (from all parts), R8: endotoxin (from all parts).

Performed by: _Date

Checked by:

Date

Annexure A

Sampling and Testing Plan

Swabs

Identification

Equipment

Testing

Testing Method/

Test

Labeling

Surface

Sample Area

Specifications

Procedure No.

Biological product

S1

Filling needle 1

25 cm2

ABC-005

S2

Filling needle 2

S3

Filling needle 3

S4

Filling needle 4

S5

Postfilter

S6

Rubber

Performed by: Checked by:

Date Date

Your Company's L

Your Company's L

Your Company's N

Your Company's N

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Healthy Chemistry For Optimal Health

Healthy Chemistry For Optimal Health

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