Sterile laboratory construction management
Sterile laboratory construction management
Sample management in sterile laboratory is an important part of laboratory testing work, involving the acquisition, identification, transportation, preparation, testing, storage, retention, disposal and recording of samples. Procedures for sample management and processing should be formulated. Procedures are used to ensure the integrity of the sample, so that the sample...
Text label: sterile pharma machinery construction, clean laboratory management, China Net Global Purification
Aseptic laboratory construction management
Sample management in sterile laboratory is an important part of laboratory testing work, involving the acquisition, identification, transportation, preparation, testing, storage, retention, disposal and recording of samples. Procedures for sample management and processing should be formulated. Use procedures to ensure the integrity of the samples, so that the samples are under strictly controlled management in each link; the samples obtained by sampling, or the samples obtained by the laboratory receiving samples, etc., should be systematically numbered to establish ledger records. The laboratory should have a special person responsible for inspection and registration of samples received. If it is an entrusted inspection, the sample manager should go through the entrustment procedures with the customer and fill in the entrustment form; for sampling samples, the sample manager should also promptly check whether the samples meet the requirements of the sampling list. Records, whether the sealing part is in good condition and whether it deviates from the standard state should also be recorded in detail. If the sample is packaged, it must be opened for inspection and verification.
Before the samples obtained in the laboratory are subjected to testing, analysis and storage, they need to go through the steps of fractionation, crushing, mixing, shrinking and pre-processing. Sample preparation methods are different for different types of samples; cross-contamination between different samples should be avoided during sample preparation, and sample preparation tools should be cleaned before proceeding to the next sample Preparation, after the test preparation is completed, put them in clean sample bottles or sample bags respectively, make sure that the test amount of each bottle is not less than 3 times the test demand of the sample test items, and add the original sample, backup, and reserve sample respectively. measurement label. The sterile laboratory should establish a unique identification system for samples. The identification of the sample is the unique mark for the identification and recording of the sample during the process of storage, testing and circulation in the laboratory, so as to avoid confusion between different samples and sample records when they are taken and archived. ; After the sample preparation is completed, the complete sample label is attached, which needs to be stored by the sample manager or tested by the testing personnel. The laboratory should have a special sample storage room, and have appropriate facilities and environmental conditions to ensure various The storage of samples that require different storage conditions, such as ventilation, moisture-proof, humidity control, cleaning, freezing, preservation and avoidance of light, etc., different types of samples have different storage conditions and should be stored separately in different areas, and good environmental protection. Monitor and record to ensure that samples are not degraded and damaged during storage, testing and handling, ensuring the integrity of test results. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for sterile laboratories and clean laboratories.
For samples with special storage requirements, the date requirements should be marked on the sample receipt registration form, and the sample management personnel should be notified; during the storage and testing of samples, the laboratory should keep the samples confidential and should not disclose customers at will. The laboratory should have necessary safety protection measures to ensure the integrity and confidentiality of the samples during the retention period. The sample management area has a special person in charge, and unrelated personnel should not be allowed to contact and understand the relevant situation of the samples. Follow up and record the storage, collection, return and processing of samples in a timely manner to prevent damage or loss of samples; the sample records that the laboratory needs to keep mainly include: sample sampling records, sample incoming sample registration ledger, sample management circulation records and sample processing Destruction of records, etc.
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