# Cody Glisson

Cody Glisson writes about contamination control and aseptic pharmaceutical manufacturing, with practical analysis of media-fill investigations, material transfer risks, and quality risk management.

- Profile: https://b2binfluencer.marketing/creators/cody-glisson/
- LinkedIn: https://www.linkedin.com/in/cody-glisson-a1242591
- LinkedIn followers: 917
- Based on 14 dated posts, latest 2026-09-15

## Summary

Most useful for practical contamination control and aseptic manufacturing analysis, especially APS investigations and material transfer risks.

- Best for: A contamination-control training provider, disinfection-chemistry supplier, or audit service targeting pharma QA and manufacturing teams.
- Not for: An AI and data-analytics platform or consumer-facing health campaign needing keynote reach and video content.
- Check first: Ask for rates, deliverables, disclosure practices, audience analytics, and comparable topic results before committing budget.

### Takeaways

- Do not stop at the first root cause in a media-fill failure.
- Contamination risk accumulates in packaging and manual transfer, not just the filling zone.
- How a team frames an APS positive determines whether it learns anything from it.

## Main ideas

- **Do not stop at the first root cause in a media-fill failure**: Glisson's most developed argument concerns aseptic process simulation (APS, or media fill) investigations that stall at operator error, an environmental monitoring excursion or procedural non-compliance. They argue APS failures are usually multifactorial, involving interactions between people, procedures, equipment, environment and process design. Their recommendation: combine Kepner-Tregoe Problem Analysis with detailed process mapping. KT forces teams to define what, where, when and to what extent controls may have failed; the map turns a complex aseptic operation into observable steps. Overlaying KT "Is / Is Not" analysis on the map lets investigators compare successful and failed controls, giving QA, manufacturing, microbiology, engineering and validation a shared evidence set instead of competing interpretations. Conclusions should rest on verifiable evidence, not opinion, and maps should be built from actual observations and batch records, not assumptions about how the process is supposed to run.
- **Contamination risk accumulates in packaging and manual transfer, not just the filling zone**: Glisson argues contamination control is often treated as a filling-area problem, though exposure can build earlier in the chain. Corrugated cardboard is not allowed in controlled environments because cellulose-based material is hygroscopic and can absorb moisture during humid transport or rain. Combined with its organic composition, moisture can let it harbour environmental microorganisms, including bacterial and fungal spores. Even sterilized primary materials commonly travel through that packaging. De-boxing areas, outer packaging layers, gloved hands, carts and contact surfaces can then become vectors. In single-bagged configurations, folds, seams, creases and irregular surfaces may never be fully contacted during manual disinfection. Because results depend on operator technique, wet contact time, coverage and procedural adherence, a process that looks compliant in an SOP or contamination control strategy can still add unnecessary risk. Audits should examine inter-operator variability, chemistry application technique, transfer routes, wet contact times and effectiveness under routine operating conditions, not just SOP compliance. Glisson notes that third-party observational audits can add assurance when internal resources are limited.
- **How a team frames an APS positive determines whether it learns anything from it**: Glisson treats quality culture as part of the technical problem. Hearing that a facility had a positive aseptic process simulation is described as one of the moments that stick with you: the result triggers a lengthy, costly and stressful investigation while production is disrupted and scrutiny intensifies. They argue that viewing the event purely as proof that the process or personnel cannot manufacture a sterile product can subconsciously encourage avoidance, silence, blame and fear — all of which undermine the investigation and future ones. The scrutiny and accountability that follow are necessary to protect patients and reinforce standards. But framing the failure as continuous improvement makes learning, sharing and proactive observation more likely, and lets the organisation see a positive as evidence that the simulation was robust enough to detect contamination risk.
- **Cleanroom chemistry supply is a patient-facing resilience question**: Glisson reads ICH Q9(R1) as saying quality risk management should weigh not only product quality but also the impact supply interruptions can have on patients. They note that the guidance names process variability, facility infrastructure, and outsourced products and services as factors affecting product availability. In aseptic manufacturing, a weak point is a contamination control strategy dependent on qualified cleaning and disinfection chemistries from a single supplier. Supplier qualification is usually handled as a compliance activity; Glisson argues it is also an effective risk management strategy. Qualifying an alternate sanitizer, disinfectant or sporicidal chemistry supplier before an emergency strengthens business continuity and protects access to critical chemistry.
- **Choose between a BSC and an isolator on total cost of ownership, not purchase price**: Recalling first seeing a biological safety cabinet (BSC) used as a critical-zone barrier in clinical manufacturing, Glisson says it was difficult to understand how much process uncertainty drives the need for variability and flexibility in early phases. In support areas for component and material preparation or staging, that uncertainty is not really a factor, changing the calculation. Facilities choosing between a BSC and an isolator in those areas should weigh the lower upfront BSC cost against the full burden: higher cleanroom build requirements, increased HVAC demand and maintenance, gowning and cleaning material costs, more intensive environmental monitoring and the investigations that come with it, and greater reliance on manual controls.
- **Industry data quality limits what AI and market reports can deliver**: Glisson's commentary on the 2026 DeFacto Biobeat Report covers AI and predictive modelling transforming drug development while drawing venture capital away from biotech; oncology leading innovation, with nearly 40% of drugs in development, while obesity therapeutics expand; China's biotech boom and US manufacturing reshoring reshaping the industry; and M&A plus licensing fuelling biotech as traditional funding tightens. The underlying argument is about evidence: Glisson questions the quality of comparative data points on page 14 of the report and says the hope that predictive modelling unlocks more traditional funding depends on the quality of the data fed into it, such as pitch decks and R&D information.

## Work to read

- [The Power of KTA and Process Mapping for APS (Media Fill) Investigations](https://www.linkedin.com/posts/cody-glisson-a1242591_asepticprocessing-contaminationcontrol-sterilityassurance-activity-7505636359601070080-UBrI)
- [Perspective Under Pressure](https://www.linkedin.com/posts/cody-glisson-a1242591_contaminationcontrol-sterilityassurance-asepticprocesssimulation-activity-7477726766707548160-KHJF)
- [How often are you auditing your material transfer processes?](https://www.linkedin.com/posts/cody-glisson-a1242591_%F0%9D%97%9B%F0%9D%97%BC%F0%9D%98%84-%F0%9D%97%BC%F0%9D%97%B3%F0%9D%98%81%F0%9D%97%B2%F0%9D%97%BB-%F0%9D%97%AE%F0%9D%97%BF%F0%9D%97%B2-%F0%9D%98%86%F0%9D%97%BC%F0%9D%98%82-%F0%9D%97%AE%F0%9D%98%82%F0%9D%97%B1%F0%9D%97%B6%F0%9D%98%81%F0%9D%97%B6%F0%9D%97%BB%F0%9D%97%B4-activity-7470143469349400577-JoX2)
- [Supply Risk and ICH Q9 (R1)](https://www.linkedin.com/posts/cody-glisson-a1242591_asepticmanufacturing-contaminationcontrol-activity-7498013506231984128-kg2E)
- [BSC or isolator in support areas](https://www.linkedin.com/posts/cody-glisson-a1242591_i-remember-the-first-time-i-saw-a-bsc-used-activity-7465868284916158464-yLpH)
- [The 2026 DeFacto Biobeat Report](https://www.linkedin.com/posts/cody-glisson-a1242591_defacto-biobeat-report-activity-7392609003933036544-1JqP)

## Brand relationships

- **Ecolab** (mention)

## Partnerships

Cody Glisson’s six posts read as practitioner commentary, not promotional or sponsored content. They walk through investigation methods, material transfer risk and quality-culture framing, without calls to action, media-kit links or rate information. The one commercial relationship mentioned is an employer connection, not a partnership offer. The material transfer post says Ecolab supports facilities with evaluating material transfer practices, disinfection workflows and contamination control effectiveness in GMP manufacturing environments. This gives buyers context for Glisson’s operational perspective and the work involved. The posts do not say whether sponsored placements are offered or refused. For brands considering a paid collaboration, the posts don’t specify formats, deliverables, disclosure practices, exclusivity terms or a booking route. Ask Glisson directly about these terms before committing budget.

## Alternatives

- Dan Lewis: Choose Dan for a broader pharmaceutical-manufacturing lifecycle campaign. In a post about Project Farma’s acquisition of SimoTech, he connects digital manufacturing and automation across project delivery, commissioning and qualification, start-up, and ongoing operations. He also makes the case for aligning engineering, quality, automation, and operations. Read Dan’s post on integrating manufacturing capabilities.
- Mike B.: Choose Mike for a campaign about building quality systems as a technical start-up grows. His post frames a QMS as infrastructure for moving from prototypes to repeatable production, with attention to risk management, corrective action, supplier quality, and reducing rework. Read Mike’s post on QMS and start-up growth.
- Santi Adavani: Choose Santi for a factory digital-twin or digital-transformation campaign. The posts introduce digital twins through applications such as production scheduling, bottleneck identification, predictive maintenance, and design visualization. Read Santi’s factory digital-twin overview and his post on descriptive digital twins.

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AI-assisted summary of public posts. Audience demographics are not available. Engagement appears only where we checked recent posts. Method: https://b2binfluencer.marketing/methodology/