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CLEAN STEAM SYSTEM - PERFORMANCE QUALIFICATION

The PQ protocol will outline a complete sampling and testing plan over 20 working days to demonstrate the ability of the generator to reliably produce steam, the condensate of which meets specifications established by the client and the US, British and European Pharmacopoeia Monographs for WFI, as appropriate. Testing will include analysis for Total Organic Carbon, chloride, sulfate, ammonia, calcium, carbon dioxide, heavy metals, oxidizable substances, total solids, and pH. Microbial and endotoxin testing will also be performed.

Sampling and testing will be conducted every day on condensate from the Clean Steam generator over a 20 working day schedule. Condensate from sample sites on the distribution system will be tested on a rotating basis for 20 working days. These studies are seasonally dependent, and should be continued over the course of a full year at an abbreviated intensity. With regard to sample size, 100 - 300 ml is preferred; sample volumes less than 100 ml are unacceptable. Microbial testing is optional in this self-sterilizing system. Endotoxin testing is required.
  • Total Count, if performed, less than or equal to 10 CFU/100 ml. The Total Heterotrophic Plate Count is the membrane filtration technique described in Section 9215 of Standard Methods for the Examination of Water and Wastewater. The medium employed will be Plate Count Agar, the incubation temperature will be 35*C ± 1*C and the incubation period will be 48-72 hours. Samples will be tested using the membrane filtration method with 100-ml portions filtered.
  • Since the steam is field sampled under non-sterile conditions, a few sporadic, individual, tests may fail. Persistent test failures with any individual test, or group of tests, will indicate a system failure.
  • When necessary, dilutions will be prepared such that colony density does not exceed 200 CFU per filter. All colonies enumerated on the filter will be described morphologically. Each morphologically distinct colony will be subcultured and the organism will be identified to the species level.
  • Endotoxin by LAL less than or equal to 0.25 EU/ml. The Bacterial Endotoxin Test will use the Limulus Amebocyte Lysate (LAL) gel-clot method. This method is described in <85> Bacterial Endotoxins Testing of USP 23.
  • Tests for pH and conductivity must be completed within four hours of receipt of sample. The remaining chemical tests must be completed within 24 hours of sampling. All testing for plate counts must be initiated within four hours and placed on incubation within eight hours of receipt of sample. Bacterial Endotoxin Testing must be completed within 4 hours if held at room temperature. Samples may be refrigerated prior to testing. This holding period can not exceed 72 hours

    Containers used to obtain microbiological samples must be sterile. Samples collected for silica analysis must be in a plastic bottle. Bacterial endotoxin test containers must be depyrogenated

Acceptance Criteria

Daily microbiological monitoring may be conducted on condensate from the Clean Steam generator over a 20 working day schedule.

Condensate from sample sites on the distribution system will be tested on a rotating basis for 20 working days
These studies are seasonally dependent, and should be continued over the course of a full year at an abbreviated intensity.

Microbial testing is optional in this self-sterilizing system. Endotoxin testing is required.
Chemical WFI Monograph in USP or EP
Microbiological: (if performed)
Total Count
less than or equal to 10 CFU/100 ml. The Total Heterotrophic Plate Count is the membrane filtration technique described in Section 9215 of Standard Methods for the Examination of Water and Wastewater. The medium employed will be Plate Count Agar, the incubation temperature will be 35*C

± 1*C and the incubation period will be 48-72 hours. Samples will be tested using the membrane filtration method with 100-ml portions filtered.

Since the water is field sampled under non-sterile conditions, a few sporadic, individual, tests may fail. Persistent test failures with any individual test, or group of tests, will indicate a system failure.

When necessary, dilutions will be prepared such that colony density does not exceed 200 CFU per filter. All colonies enumerated on the filter will be described morphologically. Each morphologically distinct colony will be subcultured and the organism will be identified to the species level.
Endotoxin by LAL (required) less than or equal to 0.25 EU/ml.

The Bacterial Endotoxin Test will use the Limulus Amebocyte Lysate (LAL) gel-clot method. This method is described in <85> Bacterial Endotoxins Testing of USP 23.
Time limits Tests for pH and conductivity must be completed within four hours of receipt of sample. The remaining chemical tests must be completed within 24 hours of sampling

All testing for plate counts must be initiated within four hours and placed on incubation within eight hours of receipt of sample

Bacterial Endotoxin Test Testing Time Limit must be completed within 4 hours if held at room temperature. Samples may be refrigerated prior to testing. This holding period can not exceed 72 hours
Containers Containers used to obtain microbiological samples must be sterile. Samples collected for silica analysis must be in a plastic bottle. Bacterial endotoxin test containers must be depyrogenated