Guidance Document - American Association of Tissue Banks

• Surface Monitoring – taking into account all different surfaces in theprocessing environment; and,• Clean area, positive pressure levels.Q4. What types of equipment must be identified in records as being used in themanufacture of tissue?A4. Any equipment that can affect the contamination status of tissues must berecorded, such as freeze-drying equipment.Q5. How would an organization determine that its equipment utilized inmanufacture of tissues is of appropriate design for its use, and is suitablylocated and installed to facilitate operations including cleaning &maintenance?A5. Determination that equipment is appropriate for use is based upon its design,location, installation and operation in regard to the potential to controlcontamination and cross-contamination of tissues during use. This should beaccomplished through the development of a Design Qualification (DQ) protocoldeveloped and executed prior to the routine use of the equipment to ensure thatthe equipment would not adversely affect/contaminate the tissue. Thedevelopment and execution of an Installation Qualification (IQ) of the equipment, ifapplicable, would then ensure that the equipment is suitably located and installed(in accordance with the equipment manufacturer’s specified requirements) tofacilitate operations as expected.Q6. In §1271.200(c) Calibration of equipment, it states that equipment requiringcalibration be routinely calibrated according to established procedures andschedules. How should an organization determine the frequency ofcalibration of its equipment?A6. An organization may consult the Operations Manual or contact the manufacturer ofthe equipment to determine and establish appropriate intervals for whichequipment should be calibrated. The organization should also take intoconsideration the specific use of this equipment within the manufacturing facility todetermine if special conditions may warrant more frequent calibration (or less) thanis recommended by the equipment manufacturer. Calibration accuracy should betraceable to accepted standards (National Institute of Standards and Technology).Q7. This section requires that calibration procedures shall include specificdirections, and where applicable, shall include limits for accuracy andprecision. What is the difference between “accuracy” requirements and“precision” requirements?A7. Accuracy should never be confused with precision. Accuracy measures how closeto a true or accepted value a measurement lies (in calibration of tolerances, it isPage 41 of 44