CHAPTER

63
Equipment Maintenance
SCOPE AND APPLICATION
This standard operating procedure (SOP) applies to regular checking and
calibrations of all the instruments and equipment installed in the blood center for
ensuring collection, processing, testing, storage, and issue/distribution of
blood/blood components as per Drugs and Cosmetics Rules 1945.
RESPONSIBILITY
Blood center technical supervisor and technicians are responsible for ensuring that
the equipment is in good working order. The equipment used for the collection,
processing, testing, storage, and issue/ distribution of blood/blood components
should be maintained in a clean and proper manner so that cleaning and maintenance
can be done easily. The equipment must be monitored, standardized, and calibrated
in accordance with SOPs prepared, taking into account the equipment manufacturers'
recommendations and the provisions of the Drugs and Cosmetics Rules 1945.
The SOPs for all equipment defining all maintenance requirements (8,
routine/preventive), regardless of whether performed by an internal or external
agency, should be written. The prepared maintenance schedule for all equipment
includes the following:
• Preventive maintenance
• Routine maintenanceAdditional maintenanceCalibration
ill equipment need preventive maintenance including cleaning.
-guat calibration, and periodic verification of performance ament or his is either
conducted by the own biomedical departNation! renufacturer's enticted by the nance
contract or any National

400
SECTION 2 Blood Center Operation
Accreditation Board for Testing and Calibration Laboratories (NABL)-certified
vendor with authoritative scope for the required parameters to be validated with
their calibrated/validated instruments having validl master traceability. The
maintenance plan as given by the manufacturer of the equipment should be adhered
to.
PROCEDURES
General Guidelines
1. All the equipment must comply with the specifications.
Processing/producing quality components requires maintenance, periodical servicing,
and fault repairing.
Each equipment must have a logbook.
The frequency of testing any equipment is determined by:
• Type of equipment
• Malfunctioning
Provisions of Drugs and Cosmetics Rules 1945
d. Review of past quality control records
Equipment Maintenance
Equipment used to collect, process, test, store and distribute blood/blood
components should be kept clean and tidily arranged for easy cleaning and
maintenance. In accordance with regulatory requirements, the equipment must be
regularly monitored, standardized, and calibrated according to the criteria given
in Table 1.
Table 1: Schedule of observation, standardization, and
calibration of equipments.
Equipment Performance Frequency
Daily Frequency of calibration
As often as
Temperature Compare against thermometer necessary
recorder
Refrigerated centrifuge Observe speed and temperature Each day of use As often as
necessary
Standardize
Hematocrit centrifuge before initial use, after repair or
adjustments, and annually
Continued