- 1.1. Pressurized cannisters used in the production or large-volume parenteral fluids may serve as a reservoir of bacterial contamination unless they are routinely disassembled, cleaned, and sterilized.
- 2.2. Filtration cannot be assumed to ensure sterility, since filters may be defective. Microbiologic quality control measures are essential.
- 3.3. Quality control procedures must be part of an established surveillance system for reporting of problems with large-volume solutions. Ideally, representatives of the pharmacy, the microbiology laboratory, and infection control should be involved.
- 4.4. Quarantine of products awaiting microbiological clearance should be strictly enforced.
- 5.5. Microbiologic quality control tests that reveal gram-negative rods must be viewed with concern and investigated appropriately.
- 6.6. Record keeping should allow precise, rapid identification of the specific patients receiving a pharmacy-prepared product.
- 7.7. The use of both positive and negative pressure to increase filtration rate conceiveably may produce a total pressure exceeding that recommended for the filter used. Therefore users of such filtration systems should periodically recalibrate pressure-monitoring gauges to ensure that excess pressure is not generated.
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