Sampling of drain points

Microbiology
1

Is it necessary to take samples from drain points located in all applicable areas?

2

Please clarify your question.
What samples are you refering from the drain points? Is it production areas or Autoclave drain points? Or are these water samples from purified water generation system? Are these water samples or something else?

3

It is production areas.

4

This is Ok. But what samples are you referring?
Are these air samples during Environmental monitoring near drain points ? OR
Are these points near drain in production areas for (microbiology viable count) media plates exposure ?
Please clarify.

5

According to PDA TR 70, It is not “necessary”, It is informative

6

Sir it is microbial monitoring of drainage in manufacturing areas to ensure microbial load of drain water is not affected due to water.we are having inhouse Sop for it.

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7

Acceptable methods for monitoring the microbiological quality of the environment in production areas include:

  • Surface Monitoring
  • Active Air Monitoring (Air sampling)
  • Passive Air Monitoring (Settling Plates)

Passive air monitoring method is the use of passive air samplers, such as settling plates (petri dishes
containing nutrient growth medium exposed to the environment). Because only
microorganisms that settle onto the agar surface are detected, settling plates can be used
as qualitative, or semi-quantitative, air monitors. Their value in critical areas will be
enhanced by ensuring that plates are positioned in locations posing the greatest risk of
product contamination. The data generated by passive air sampling (settling plates) can be useful when considered in combination with microbiology results from other types of air samples.

Processing equipment and systems should be equipped with sanitary fittings and valves. With
rare exceptions, drains are considered inappropriate for classified areas of the aseptic processing
facility other than Class 100,000 (ISO 8) areas. It is essential that any drain installed in an
aseptic processing facility be of suitable design.

Considering above aspects it would be preferred to keep settling plates near drain points to assess level of contamination at these points in addition to other strategic places.

2 Likes
8

Thanks sir

9

You are always welcome…!!

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10

PDA TR 70:

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image3178×483 105 KB

11

Thanks for your reply sir

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12

Bio barrier cartridge filter should be used in drain point of aseptic area.

13

not exactly, but you have to validate hose pipe to take water sample .

14

First Bio barrier cartridge filter should not be used in drain point of aseptic area because it have been already specified area
then no needs of Drain in Aseptic Area As per sCHEDULE M

15

how u can perform CIP and SIP of holding tank in aseptic area without drainage facility.

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16

**TYPE B: cleaning

In this case, validation of the effectiveness of the cleaning procedure in removing residues to the required level is mandatory.

B. SELECTION OF CLEANING METHOD

  • Manual cleaning
  • Semi automatic procedures
  • Automatic procedures
  • CIP (Clean-in-place)
  • COP (Clean-out-of-place)

In case of SIP of Product dismentale all accessories that exposed direct in contact with Sterile powder .

17

i am talking about SIP of holding tank. how u perform CIP/SIP of holding tank in aseptic area.

18 
     ELECTRICAL HEATER
     HEAT EXCHANGER BY INDUSTRIAL STEAM
19

i have not seen SIP by heat exchanger. SIP of tank is done by SIP module.

20

Thanks and good information.
Sir, i need you advice on the below
My facility is a non-sterile tablet manufacturing facility.

  1. In Grade D area (ISO 100,000) i have drain point. While keeping settle plate do i need to keep one near/close to the drain point. Is it a necessity/requirement?
  2. should the risk assessment consider drain point as one of the location to determine the worst case location
  3. Is there a guidance document on performing environmental monitoring studies.

Appreciate your reply

Regards
Jay K