In this article, we will discuss the Clean Steam Validation procedure using in pharmaceutical sterile manufacturing.
- A sampling of Pure steam for Bacterial Endotoxin Testing & Viable Count
- Samples for Bacterial endotoxin evaluation should be collected in dehydrogenated tubes/bottles.
- Remove the cap from the bottle immediately prior to obtaining a sample.
- While samplings avoid direct contact with the mouth of tubes/bottles.
- Allow the steam to flow for approximately 1 minute.
- While sampling wears gloves and opens the sampling valve slowly so that steam is converted into condensate.
- Take the holder and hold the sampling bottle from the neck of the bottle.
- Take the sampling bottle near the valve band collect the condensate.
- Obtain the sample by filling the bottle.
- Do not allow the bottle or the water in the bottle to come in contact with the valve
- Fill the bottle, without overflowing the bottle.
- Tighten the cap securely, Close the valve
- Fill in the information on the face of the bottle, as required.
- Collect all the sample bottles as per the schedule and store them in a refrigerator (2-8ºC) if bacterial analysis will not be initiated within 2 hours after sample collection.
- Sampling of Pure steam for chemical analysis
- Samples for chemical analysis should be collected in a clean and dried bottle.
- Remove the cap from the bottle just prior to obtaining a sample.
- While samplings avoid direct contact with the mouth of tubes/bottles.
- Allow the steam to flow for approximately 1 minute.
- While sampling wears gloves and opens the sampling valve slowly so that steam is converted into condensate.
- Take the holder and hold the sampling bottle from the neck of the bottle.
- Take the sampling bottle near the valve band collect the condensate.
- Rinse the bottle with water to be sampled at least three times.
- Do not allow the bottle or the water in the bottle to come in contact with the valve.
- Fill the bottle and remove the bottle from the sample valve and place the cap on the bottle as quickly as possible and ensure that no air bubble is entrapped.
- For TOC analysis take the sample in the separate TOC vials collect the sample by overflowing the vials and close it immediately.
- Tighten the cap securely.
- Close the valve.
- Fill in the information on the face of the bottle, as required.
- Collect all sample bottles per the schedule and analyze the sample within 2 hours of sampling.
- Ensure that testing, in any case, is initiated within 24 hours after sampling
Chemical Investigation
- pH: Steam condensate is analyzed for pH value at 25ºC. It should be between 5 -7.
- Conductivity: Conductivity should be tested with calibrated conductivity meter at 20ºC.
- Conductivity should not be more than 1.3µS/cm.
- Microbiological Investigation:
- Viable Count
Procedure
Take a minimum of three condensate samples (sample volume 300ml each) from each Supply Point.
Requirements
10 CFU/100ml
- Pyrogen Test
Procedure
Endotoxin determination is performed according to the bacterial endotoxin test of the USP/ Take a minimum of three condensate samples (sample volume 100ml each) from each supply point.
Requirements
It should not be more than 0.2 EU/ml as in water for injection
Frequency
Monthly / Any major maintenance occurs.
CLEAN STEAM VALIDATION REPORT
| S. No | Parameters | Specifications | |
| 1 | Chemical Investigation
|
pH |
5.0 – 7.0 at 25°C |
|
Conductivity |
NMT 1.3ms/cm at 25°C | ||
|
TOC |
NMT 0.5mg/liter or ppm | ||
| 2 | Microbiological Investigation
|
Viable count
|
NMT 10 CFU/100 ml
|
| Bacterial endotoxin | ≤ 0.25 EU/ml | ||
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