AAMI TIR14 pdf free download

AAMI TIR14 pdf free download.Contract sterilization using ethylene oxide.
3 Selection of sterilization facility 3.1 Initially, an evaluation is required to determine whether sterilization should be performed by a contract facility or whether the capabilities exist for in-house processing. The manufacturer’s selection of a location for sterilization should be well informed. Once this evaluation has been performed and it has been determined that contract sterilization is the proper choice, a number of factors require assessment to identify a contractor that best suits the manufacturer’s needs. Some of the issues affecting the choice of location include the following: a) proximity of the facility to the manufacturer or the product distribution center and end user; b) sizes and available capacity of chambers in relation to the expected volume of manufactured material; c) processing capability of the facility with respect to preconditioning (if used), sterilization, and aeration (if used); d) cost of processing (includes sterilization and shipping); e) Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), and safety compliance;3.3 For facilitation of the assessment procedure, it is often helpful to have a predetermined assessment document that reflects the domestic and international regulatory requirements. This document enables the assessor to make an appropriately informed decision with regard to the contractor’s compliance. Once the assessment has been completed, the assessor should provide a written report stating the acceptability of the contractor. This report should list corrective actions that need to be taken, if any. It is then the contractor’s responsibility to address and document these corrective actions and to provide such documentation to the assessor to enable closure of the assessment process. In some situations, the contractor may not agree to perform the proposed corrective actions, perhaps because of conflicting requirements among multiple customers or equipment or operational reasons. In this situation, the assessor must determine whether the refusal to implement the suggested corrective actions is unacceptable or whether the company can tolerate the existing conditions. If no corrective action is identified, a report should be issued stating that an assessment has been performed. On completing any corrective action, the manufacturer should issue a letter to the contractor closing the assessment. If the corrective action cannot be completed within a short period of time, a timetable outlining the anticipated completion dates should be provided to the assessor. The assessment of the sterilization facility under consideration, in conjunction with logistical concerns, provides the manufacturer with sufficient information to make a well-informed selection. The final requirement for the acceptance of the location is the documentation of the logic and criteria used in the selection process.4 Written agreement between product manufacturer and contract sterilizer 4.1 Before contract sterilization processing begins, a written agreement that outlines the services and procedures to be supplied and followed by both parties shall be developed and signed. Requirements for the contract between the two parties are found in 21 Code of Federal Regulations 801.150(e). This section of the code requires a written contract when interstate shipping is involved. For intrastate services, a contract is recommended to ensure compliance with good manufacturing practice (GMP) requirements for device master records (21 CFR 820.181). The regulation specifies the contents of the agreement, including a requirement for a detailed delineation of the sterilization process. It is necessary to examine the contract sterilizer’s compliance with this regulation. In addition to the requirements of 21 CFR 801.150, good business practices may require other inclusions in the written agreement to clarify the division of responsibilities.AAMI TIR14  pdf download.