Validation

Resources from this center
Archived resources from this center

The Northeast Biomanufacturing Center and Collaborative (NBC2) has created this resource that provides an overview of the topic of validation. Visitors can download various resources that cover this specific topic of biomanufacturing. These resources include validation protocols produced by Montgomery County Community College, forms for autoclave protocol and monitoring, and a presentation by Lara Dowland on the topic of validation. Additionally, chapter 4, "Validation," of the Introduction to Biomanufacturing textbook, created by the Northeast Biomanufacturing Center and Collaborative (NBC2), is included.

Below is a list of the files contained within the .zip attachment. The size of each file is included in parenthesis.

Validation (13 files 3.8 MB)

Appendix A: Master Glossary (22886923819658983-masterglossary-restricted.pdf 499 KB)
Validation: Active Learning and Lab Activity (356640917392927764-validation-active-learning-and-lab-activity-bioman-2014.pdf
Validation Competencies List (560063306686967292-competencies-validation.pdf 87 KB)
Chapter 4: Validatoin (595781148110118460-chapter-4.pdf 1 MB)
Validation (776742480116890521-lara-dowland-validation.pdf 337 KB)
Overview: Engineering Unit (973277756482382945-engineering-unit-overview.pdf 395 KB)
Forms
- FORM: Autoclave Monitoring (1921587211637956-val-6-autoclave-monitoring-form-mc3.pdf 79 KB)
- Example of Autoclave IQ protocol (369937549320817350-val-1-autoclave-iq-mc3.pdf 46 KB)
- Example of an OQ protocol for an autoclave (454340178907131105-val-2-autoclave-oq-mc3.pdf 48 KB)
SOPs
- SOP: Tuttnauer 3850 ELV Autoclave Operation (575933624556703122-val-4-tuttnauer-3850-elv-autoclave-operation-sop-mc3.pdf 260 KB)
- Filter Integrity Testing Protocol (645533663672594880-filter-validation-protocol.pdf 658 KB)
- Operational Qualification for Autoclave (769376395746762037-val-3-operational-qualification-for-autoclave-sop-mc3.pdf 126 KB)
- SOP: Operation of Harvey Sterilemax Autoclave (841879538236582433-val-5-harvey-sterimax-operation-sop-mc3.pdf 91 KB)