Quality Alchemist (品質煉金術師): STERIS WORKSHOP - A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom

2021年11月18日星期四

STERIS WORKSHOP - A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom

STERIS WORKSHOP named “A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom” was held by ISPE Singapore Affiliate on 18 Nov 2021. This workshop covered a risk-based approach to an Aspergillus brasiliensis and Chaetomium contamination in a Cell and Gene Therapy Cleanroom. There were two speakers and they are Mr. Jim Polarine Jr. MA. (Senior Technical Service Manager, STERIS Corporation) and Mr. Dan Klein (Senior Technical Service Manager, STERIS Corporation).

In the beginning, Mr. Jim Polarine discussed the contamination source including aging facility, materials spore, operator in cleanroom, spill out or residual during process, touching utilities, and contaminated equipment, etc.

Then Mr. Polarine briefed the contamination control strategy that disinfectants are balancing efficacy, stability, compatiability, safety, etc.

And then he introduced the process of cell and gene therapy from “Thaw the blood” to isolate T-cell and natural killer (NK) cells, … to fill bags or vials and freeze.

He also mentioned some common contamination control throughout the process using H2O2, 70% IPA, etc.

Mr. Polarine demonstrated the efficacy of IPA and Sporicide for B. subtilis under different surfaces like stainless stell, self-seal pouch and polycarbonate.

The diagram showed different aseptic products had different efficacy under different contact time.

Some quality tools were introduced such as Ishikawa diagram and 5 Whys for problem analysis. One of case showed was Aspergillus in cell and gene therapy facility.

He also demonstrated how to clean and disinfect the biosafety cabinet (BSC). He also shared recent FDA 483 observation such as visible black and brown stains on the ISO 5 Cleanroom celling tile, recalls due to mold contamination, etc.

The second speaker Mr. Dan Klein then discussed the molds common to cleanrooms and cold rooms. There are many different species with different level or resistant.

Mr. Klein showed the fungal spore efficacy spectrum that Chaetomium & Aspergillus spp were more resistant.

Then he used Aspergillus to explain different contaminations such as high pressure impingement sprayers made holes in walls.

The highest risk for contamination is Cart Wheel during pass-through clean and dirty area.

After that Mr. Klein showed the Aspergillus brasiliensis spores using SEM that was difficult to destroy.

Chaetomium testing time kill was demonstrated. Different method using Phenol A, Phenol B and 70% IPA on glass, stainless steel and flooring were discussed.

Finally, Mr. Dan Klein shared the article on “Wet Contact Time”.

Mr. Jim Polarine discussed the cleaning methods including wax on wax off, overlapping unidirectional strokes, removal of residues, particles and microbes, etc. Lastly, he showed a casy study of construction event for triple clean - after 2x cleaning with fungicidal and 1x cleaning with sporicide. The critical area is cleaned.