Failure Mode and Effects Analysis to Reduce Risks of Errors in the Good Manufacturing Practice Production of Engineered Cartilage for Autologous Chondrocyte Implantation

Roseti, Livia; Serra, Marta; Bassi, A.; Venezian, Teresa; Maso, Alessandra; Fornasari, Pier Maria; Denia, Patrizio Di; Storni, Elisa; Grigolo, Brunella

doi:10.2174/1573412911666150604233714

Cited by 5 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The identified failure modes were characterized by three variables: the likelihood of occurrence (O), the severity of the potential effects (S), and the chance of detection before affecting process/product quality (D). Variables were quantified using specific 1-10 ranking scales (Tables 1-3) obtained by adjusting previously employed ones [1,18] to the 3D bioprinting context. By multiplying O × S × D, the Risk Priority Number (RPN) was calculated.…”

Section: Product Quality Evaluationmentioning

confidence: 99%

Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

et al. 2021

Self Cite

View full text Add to dashboard Cite

Extrusion bioprinting is considered promising in cartilage tissue engineering since it allows the fabrication of complex, customized, and living constructs potentially suitable for clinical applications. However, clinical translation is often complicated by the variability and unknown/unsolved issues related to this technology. The aim of this study was to perform a risk analysis on a research process, consisting in the bioprinting of a stem cell-laden collagen bioink to fabricate constructs with cartilage-like properties. The method utilized was the Failure Mode and Effect Analysis/Failure Mode and Effect Criticality Analysis (FMEA/FMECA) which foresees a mapping of the process to proactively identify related risks and the mitigation actions. This proactive risk analysis allowed the identification of forty-seven possible failure modes, deriving from seventy-one potential causes. Twenty-four failure modes displayed a high-risk level according to the selected evaluation criteria and threshold (RPN > 100). The results highlighted that the main process risks are a relatively low fidelity of the fabricated structures, unsuitable parameters/material properties, the death of encapsulated cells due to the shear stress generated along the nozzle by mechanical extrusion, and possible biological contamination phenomena. The main mitigation actions involved personnel training and the implementation of dedicated procedures, system calibration, printing conditions check, and, most importantly, a thorough knowledge of selected biomaterial and cell properties that could be built either through the provided data/scientific literature or their preliminary assessment through dedicated experimental optimization phase. To conclude, highlighting issues in the early research phase and putting in place all the required actions to mitigate risks will make easier to develop a standardized process to be quickly translated to clinical use.

show abstract

Section: Product Quality Evaluationmentioning

confidence: 99%

Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

“…An example of adoption of a failure mode and effects analysis (FMEA) can be seen in Lopez et al [54] whereby risks were identified and prioritized and a severity/occurrence matrix was highlighted for the production of liver progenitor cells. In another study it was shown that the implementation of an FMEA/ FMECA method revealed the causality of human errors (either due to errors or inadequate training) and the subsequent introduction of 26 criticalities within GMP production of autologous chondrocyte implantation [55]. Currently, a major challenge in the field for the implementation of similar approaches is the absence of reference standards for determining acceptable risk levels and this should be further explored.…”

Section: Risk Assessment and Managementmentioning

confidence: 99%

Bioprocess engineering strategies for autologous human MSC-based therapies: one size does not fit all

Papantoniou¹,

Lambrechts²,

Aerts³

2017

Cell Gene Therapy Insights

View full text Add to dashboard Cite

“…In the standards of GMP, drug production materials in the warehouse and accessories storage have strict requirements, including raw material storage temperature, humidity, classification storage standards, and materials access standards. The management system, firstly developed in industrial and transport sectors, has been recently applied also in the healthcare to ameliorate patient safety [7].…”

Section: Gmp Standardmentioning

confidence: 99%

Research of a Pharmaceutical Enterprise Warehouse Management System Based on RFID Technology

Xiang¹

2016

View full text Add to dashboard Cite

Under the background of a pharmaceutical company, this paper describes the problems in ex-warehousing, warehousing, inventory management process, which including low level of information, excessive label work and manual production operations, complex work processes, high working strength in employees and so on. In order to solve these problems, this paper makes a description of these issues and proposes the application of RFID technology in pharmaceutical warehouse management system, which based on the characteristics of RFID technology for material storage and automatic bulk information collection. RFID technology is widely used in logistics management and process optimization as a new type of Internet technology. Warehouse management system based on RFID technology can combine the GMP certification requirements and standards, automatically complete the input and output of information. So that it can effectively assign storage location automatically, avoid the medicine pollution problem caused by improper manual operation, improve operation efficiency, reduce error rates. The application of RFID technology in medicine warehouse management system is an exploration in domestic pharmaceutical enterprise. It is of great importance to optimize the enterprise storage management.

show abstract

Failure Mode and Effects Analysis to Reduce Risks of Errors in the Good Manufacturing Practice Production of Engineered Cartilage for Autologous Chondrocyte Implantation

Cited by 5 publications

References 0 publications

Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

Bioprocess engineering strategies for autologous human MSC-based therapies: one size does not fit all

Research of a Pharmaceutical Enterprise Warehouse Management System Based on RFID Technology

Contact Info

Product

Resources

About