Performance qualification: Critical to validation

Ajju Agnihotri; Saranjeet Kaur; Jitender Kumar; Ravinder Chahal

doi:10.4103/0973-6247.106711

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ILLUSTRATION

Year : 2013 | Volume : 7 | Issue : 1 | Page : 4-5

Performance qualification: Critical to validation

Ajju Agnihotri, Saranjeet Kaur, Jitender Kumar, Ravinder Chahal
Department of Transfusion Medicine, Max Super Specialty Hospital, Shalimar Bagh, Delhi, India

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Date of Web Publication

2-Feb-2013

How to cite this article:
Agnihotri A, Kaur S, Kumar J, Chahal R. Performance qualification: Critical to validation. Asian J Transfus Sci 2013;7:4-5

How to cite this URL:
Agnihotri A, Kaur S, Kumar J, Chahal R. Performance qualification: Critical to validation. Asian J Transfus Sci [serial online] 2013 [cited 2023 Mar 24];7:4-5. Available from: https://www.ajts.org/text.asp?2013/7/1/4/106711

Validation is an essential and vital prerequisite for commissioning of equipments. ^[1] It ensures that the intended process meets the desired outcomes. ^[2] WHO defines validation as the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result. Validation of equipments involves completion of three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Compliance to all three phases improves the overall knowledge of the process and assures that the process has been well developed, well maintained, and operates as it should. It reduces the risks involved and expenses of routine processes. ^[3],[4] Importance of either of these parameters cannot be undermined in day to day operations of blood bank.

We present a case of Refrigerated Blood Component Centrifuge "buckets" which were used for preparation of components. After using the buckets for about 3-4 months it was noticed that the central septum had deviated at its top end, towards the centrifugal force [Figure 1]. The buckets, however, continued to be in regular use as no harm was anticipated.

Figure 1: Centrifuge buckets showing bulge in the median septum and deviation at the top edge

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Nearly two months later, a unit of whole blood ruptured in the centrifuge while it was being centrifuged at 3200 rpm for 10 min. When attempts were made to remove the ruptured blood bag from the centrifuge bucket, the technical staff realized that the ruptured bag was entangled in the septum of the centrifuge bucket. The blood bag had to be cut away from the impacted bag in the septum in order to be removed [Figure 2].

Figure 2: Centrifuge bucket showing edges of ruptured blood bag trapped in the septum

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Root cause analysis of the event revealed that the medial septum of the all four centrifuge buckets had developed bulges at their lower ends. The top most part of the septum also showed deviation towards the centrifugal force. The heavy centrifugal force lead to a crack at the lower end of the septum and pushed the blood filled blood bag through the crack. The plastic sheet of the blood bag eventually ruptured leading to spillage of a precious unit of whole blood. Failure to correlate the gradual changes in the component buckets to the performance qualification of the equipment lead to the discarding of three potential blood components, which could have been prevented. Although the IQ, OQ, and PQ were performed for the refrigerated centrifuge by evaluating the quality of components, the buckets were not individually assessed for their long-term performance.

This case emphasizes the role of performance qualification (PQ) phase of validation. PQ must be carried out over longer periods of performance for all aspects of procedures, processes, equipments, materials, activity or systems as a whole. It helps test the ability of the process to perform over longer periods of time within tolerance, deemed acceptable.

References

1.	British Committee for Standards in Haematology, Transfusion Task Force, Allard S, Burgess G, Cuthbertson B, Elliott C, et al. Guidelines for Validation & Qualification, including Change Control, for Hospital Transfusion Laboratories. Transfus Med 2012;22:5-43.
2.	Supplementary guidelines on good manufacturing practices: Validation. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. 40 ^th Report. Geneva: World Health Organization; 2006.
3.	World Health Organization. WHO Technical Report Series No. 961; Annex 4. Geneva: WHO; 2011. p. 29-33.
4.	Böcker W, Clark M, Desaint C, Davis R, Distler P, Izaguirre C, et al. ISBT-Guidelines for validation and maintaining the validation state of automated systems in blood banking. Vox Sang 2003;85 Suppl:S1-14.