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. Table 1 lists the required frequencies that are stated in CFR Title 21 section 606.60.8
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.
Table 1. Equipment Performance Checks and Frequency.8Equipment
| 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
|
8. Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart D, Section 606.60 "Equipment". Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-D/section-606.60.
