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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Equipment

Concepts:
  • Evaluate equipment before use
  • Maintain according to manufacturer's instructions
Many of the cGMP requirements related to equipment that are included in the general drug manufacturing requirements (CFR Title 21 Part 211 subpart D) and the specific blood and blood component requirements (Title 21 Part 606 Subpart D) are probably already implemented in the laboratory to be in compliance with the Clinical Laboratory Improvement Amendments (CLIA) regulations and laboratory accreditation requirements. These requirements include:
  • Written equipment maintenance procedures
  • Defined calibration frequency
  • Documentation of maintenance and function checks
Equipment must be standardized and calibrated on a regularly scheduled basis; the required frequency should be defined in the facility's Standard Operating Procedures Manual. The equipment must perform as intended. If calibration and standardization fail, the equipment must be removed from service. After repair, equipment must be tested and recalibrated as required by the manufacturer's instructions before being placed back into use.
The table below lists the required frequencies that are stated in CFR Title 21 section 606.60.

Equipment
Performance Check
Frequency
Frequency of Calibration
Temperature recorder
Compare against thermometer
Daily
As necessary
Refrigerated centrifuge
Observe speed and temperature
Each day of use
As necessary
Hematocrit centrifuge
As required by laboratory procedure manual
As required by laboratory procedure manual
Standardize before initial use, after repairs or adjustments, and annually; Timer every 3 months
General laboratory centrifuge
As required by laboratory procedure manual
As required by laboratory procedure manual
Tachometer every 6 months
Automated blood typing machine
Observe controls for correct results
Each day of use
No required frequency
Blood container scale
Standardize against container of known weight
Each day of use
As necessary
Water bath
Observe temperature
Each day of use
As necessary
Rh view box
Observe temperature
Each day of use
As necessary
Autoclave
Observe temperature
Each time of use
As necessary
Serologic rotators
Observe controls for correct results
Each day of use
Calibrate speed of rotator as necessary
Laboratory thermometers
If non-certified thermometer, check against an appropriate thermometric standard device
At least annually, if non-certified thermometer
Before initial use
Electronic thermometers
--
--
Monthly
Vacuum blood agitator
Observe weight of the first container of blood filled for correct results
Each day of use
Standardize with container of known mass or volume before initial use, and after repairs or adjustments