Guidance Document - American Association of Tissue Banks

VII. ProcessingQ1. In §1271.190 Facilities (a) General, it requires that a facility used in themanufacture of tissue shall be of “suitable” size, construction, and locationto facilitate cleaning, “relevant” maintenance, and “proper” operations. Howis an organization to determine if their facility is of suitable size, constructionand location to facilitate cleaning, relevant maintenance and properoperations?A1. It’s up to each establishment to determine and establish the qualification of theirfacility related to facility cleaning and sanitation. If a facility, for whatever reason,cannot be adequately cleaned so as to minimize the risk of tissue contamination orcross-contamination between donors and consistently operate within establishedcontrol limits, it is not appropriate for the manufacture of tissues. For processingoperations, this should be determined by a verifiable cleaning program supportedby environmental monitoring activities, as specified in 1271.160 (b) Functions (5),and 1271.195 Environmental control and monitoring.Q2. What temperature and humidity controls should be in place?A2. If processing steps in the manufacture of tissue have identifiable parameters formaintaining a certain temperature and/or humidity, or the potency and efficacy ofthe reagents used in the manufacturing of tissue may be affected adversely bytemperature and/or humidity, methods to monitor and document these conditionsmust be established. Each establishment would have the responsibility ofdeveloping an appropriate stability protocol to determine if temperature andhumidity could reasonably be expected to have an adverse effect on the tissue. Inthese situations, an establishment would be required to establish and maintainprocedures to adequately control and monitor environmental conditions and toprovide proper conditions for operations.Q3. How often should I perform environmental monitoring?A3. Depending on the particular environmental factors at a processing facility, and thetype of operations performed there, environmental controls, along with the typeand frequency of monitoring should be defined in procedures. Regular monitoringshould be performed to show cleaning procedures are adequate, and that theenvironmental control systems are capable of maintaining the degree of controlspecified. Establishing pass/fail criteria, along with alert and action limits, for testresults should be defined in procedures along with corrective action measures forout-of-spec (OOS) conditions identified. The following is a list of areas that mightbe considered as candidates for environmental monitoring:• Non-viable particulate air monitoring;• Viable particulate air monitoring;Page 40 of 44