Sterile laboratory hood

The sterility testing area is located in an area of the microbiology laboratory. The area contains a gowning room and sterility testing room. Each testing room contains a unidirectional flow HEPA hood. 

Laboratory equipment such as incubators, refrigerators, laminar flow hoods, depyrogenation ovens, sterilizers, etc., will be qualified using the same approach as that used for process equipment and utility systems. 

Whereas readers are referred to these specific documents for details available on the Web site http //www.fda.gov/cder/fdama, some of the specifics are briefly mentioned here. The essence of this guidance emphasizes the importance of the overall quality assurance in manufacturing a PET radiopharmaceutical. All equipment and measurements used in the manufacture must be validated. The areas and hoods in which PET radiopharmaceuticals are manufactured must be run in a sterile condition. The personnel responsible for the manufacture must be well trained in the methodology, and an appropriate number of personnel are required in a production laboratory. Each step of the production must be verified and records must be maintained. The sterility and pyrogen testing of the finished product must be performed by appropriate methods. If a PET radiopharmaceutical is to be commercially distributed, appropriate containers and techniques must be adopted for safe shipments. 

The isolation was carried out in a special laboratory in a laminar flow fume hood in order to ensure sterility and provide personal protection. All solvents were rendered sterile by filtration through a 4-micron filter. The number of spores was <20 cfu/g and the material was endotoxin free. A crystal structure is shown in Figure 17 and NMR data and the compound itself are shown in Figure 18. A summary for the synthesis of 1 through the first two campaigns is shown in Table 9. 

Probes can be obtained from our laboratory or synthesized as described earlier (9). Alk-C13 and Alk-C18 can be obtained from Otava Ltd. and Sigma-Aldrich, respectively. The user should avoid multiple freeze-thaw cycles of the fatty acid probe stocks as this may compromise reagent quality. Dissolve all probes in a tissue culture hood (sterile environment). 

Second-round PCR-reaction mixture includes 1 pL first-round product and 20 pmol of each internal primer the concentrations of PCR buffer, dNTPs. and Taq polymerase are the same as in the first-round PCR, and again sterile distilled water is added to bring the total volume to. 50 pL. As for the first round of PCR, we aliquot the reaction mixture in the laminar-flow hood, prior to addition of the first-round products and 30 pL paraffin-oil overlay in the separate laboratory. PCR conditions are identical to the first round and PCR products may be left at room temperature overnight prior to gel electrophoresi.s. 

RNA IS extracted by a method based on that described by Chomczynski and Sacchi (80). We have found this to be more satisfactory than the CsCl extraction method, which was associated with problems of contamination between samples. RNA IS extracted in a laminar-flow hood, using sterile 1 5-mL tubes and plugged pipet tips gloves are worn at all times to avoid RNA degradation owing to RNases RNA is extracted in a separate laboratory from that in which RT-PCR is performed to avoid risks of contamination of RNA by amplified product RNA should be extracted in parallel from a non-APL patient sample or cell-line (e g, HL60) to exclude contamination of patient RNA samples with the leukemic clone. 

The biggest challenge facing the microbiologist is microbial contamination, especially airborne microorganisms. To minimize this problem, commercial laboratories will use laminar flow hoods, which maintain a localized sterile environment for manipulation of cultures and microbiological analyses (Section 18.10). Although expensive, their use reduces losses of contaminated media and employee time and effort. 

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