使用（或采购）旧设备的清洁残留方面的考虑

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使用（或采购）旧设备的清洁残留方面的考虑
选自PDA TR29 CLEANING VALIDATION
10.5.2   Used  Equipment
When adding used equipment to a cleaning validation program, the points noted in the previous section about new equipment apply. An additional point to consider for used equipment is equipment history. It is desirable to have as much information as possible about the compounds that were previously manufactured in the equipment. Some information of  interest would be the type of  compound (e.g., pharmaceutical or pesticide) and the hazards and/or toxicity of  the compounds. That information may be used to determine an acceptable cleaning process for the used equipment, and to set acceptance limits for those compounds for a cleaning verification evaluation following the cleaning process.
If  little to no information about the previous compounds is available, it may be possible to identify potential manufactured products by FTIR analysis of  swabbed surfaces. Additional surface modification steps (e.g., descaling, pickling, passivation, reglassing, repolishing) may be taken to assure the cleanliness of  the equipment. An evaluation of  cleanliness may also entail TOC analysis (as a general measurement of  equipment cleanliness) and/or FTIR analysis of  sampled surfaces (to confirm removal of  any potentially objectionable organic residues identified in the precleaning FTIR analysis). The justification for a firm’s decision should be captured in a documented risk-consideration. In some cases, the additional cost of  the steps taken for used equipment may negate any cost benefit; therefore, this consideration should be made well in advance of  the purchase.

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