QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 20

SOP No. QCS-008.00 Effective date: mm/dd/yyyy
Approved by:

8.3.5.3 sampling technique
8.3.5.3.1 Special Precautions to Be Taken during Sampling
• Follow aseptic technique rules. Wear proper garments, sterile gloves, and mask.
• Keep the sampling bottle away and do not open it until the sampling point is ready.
• Be sure that the sampling point is in proper condition and under high pressure.
• Avoid leaky ixtures that may contaminate the samples with bacteria from the outside surface.
• Disinfect the sampling point from inside and its surrounding with 70% ethyl alcohol or 3%
H 2 O 2 for 2 min.
8.3.5.3.2 Special Precautions during Sampling
• Pure steam: Through an autoclavable condenser, pass the steam for 30 min and then col-
lect the sample in a tightly closed container with a vent passage.
• Bacterial endotoxin: Through apyrogenic connection, pass the water for about 1 min and
then collect the sample in apyrogenic bottle. All materials coming in contact with test
materials and reagents must be pyrogen free. Careful techniques must be used to prevent
contamination with environmental endotoxin.

8.3.5.3.3 Multistep Sampling Methods
• Open the sampling point to maximum for about 30 s with pulse lushing (quick open and
close) to purge any dust and residual of the disinfectant.
• Remove the cap from the bottle immediately prior to obtaining a sample.
• The cap may be placed on a clean surface with the open side facing upwards. The sample
side of the cap should not come in contact with any surface, including the fingers or the
hand of the individual during sampling.
• Adjust the sampling point to an adequate level, open the sampling bottle under a stream of
water in a downward direction and then invert the bottle quickly upward to collect the
sample. Fill the bottle, without letting the sample to overflow. Allow sufficient space (1″ or
2.5 cm) at the top of the bottle to facilitate mixing of the sample by shaking.
• Do not allow the bottle or the water in the bottle to come in contact with the source.
• Remove the bottle from the sample stream and place the cap on it as quickly as possible.
• Samples must be properly labeled, and must include the following:

Date: Name of sampler:

Time of sampling: Sampling point:

Special notes:

Be sure that the stopper of the bottle is not mishandled or in contact with any source of
contamination. Cover the neck of the bottle with a new sterile wrapped material.

8.3.5.3.4 MicropreSure® In-Line Filtration Sampler
• Preparation of in-process water samples using the MicropreSure ® device.