Cody Glisson

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.

The post lists what a usable map must include: all sterilization and filtration steps, routine and non-routine interventions, material transfers, glove manipulations, equipment adjustments and line stoppages — plus evidence such as FIT results, sterilization records, video review, intervention logs and environmental and personnel monitoring data. It also says to evaluate where contamination did not occur, since its absence elsewhere can be equally informative.

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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.

Glisson used a family explanation to make the point: after the topic came up with their son, the post includes the son's drawing of a wet box in a delivery truck to illustrate why material transfer presents a spore risk.

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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.

Glisson explains APS in plain terms: a worst-case dress rehearsal in which the simulated process fills containers with nutrient-rich medium instead of product, encouraging growth of any microorganisms present. This provides holistic evidence that the process can prevent contamination during routine operations.

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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.

The post poses a direct test question: if your cleanroom chemistry supplier experienced a disruption tomorrow, how resilient is your contamination control programme?

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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.

The post asks peers what they have observed rather than making a firm recommendation, focusing on how facility decisions are actually made.

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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.

Glisson flags the report page where comparative data points look questionable, and ties the funding question to the calibre of source material, such as pitch decks, rather than to the models themselves.

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The post offers a detailed method and practical checklist.

The post combines Kepner-Tregoe Problem Analysis, which defines what, where, when and to what extent controls may have failed, with process mapping, which turns a complex aseptic operation into observable steps.

• It overlays KT Is/Is Not analysis on the process map to compare successful and failed controls, and calls for QA, manufacturing, microbiology, engineering and validation teams to work from one source of truth.
• It warns against stopping at operator error, environmental monitoring excursions or procedural non-compliance.
• Practical cautions include using actual observations and batch records; covering sterilization and filtration processes, routine and non-routine interventions, material transfers, glove manipulations, equipment adjustments and line stoppages; and evaluating where contamination did not occur.
• It recommends verifiable evidence such as FIT results, sterilization records, video review, intervention logs, and environmental and personnel monitoring data, and notes that APS failures are often multifactorial.

For brands planning a campaign

For a contamination-control or APS investigation brief, this offers a ready-made training or workshop framework. A campaign can showcase a structured KT-plus-process-mapping method, emphasize evidence discipline and provide practical templates for cross-functional investigation teams.

The post explores the human side of a technical failure.

The post recounts hearing that a facility had discovered an aseptic process simulation positive, or media fill failure.

• It explains that an APS is a worst-case dress rehearsal that fills containers with nutrient-rich medium instead of product to encourage microbial growth.
• Contaminated units trigger a lengthy, costly and stressful investigation.
• The post argues that treating the event only as an organizational failure can foster avoidance, silence, blame and fear—all counterproductive during the investigation and future ones.
• Focus, scrutiny and accountability remain necessary to protect patients and reinforce standards, but framing the failure as continuous improvement can help teams better understand the process and strengthen quality culture.

For brands planning a campaign

Useful for internal quality-culture campaigns or leadership communications on contamination control. It pairs technical methods with the human factors, showing how fear and blame can undermine investigations.

The post offers a concrete entry point into aseptic control.

The post asks how often facilities audit material transfer processes.

• Cody Glisson describes explaining the topic to their son and sharing the son's drawing of a wet box in a delivery truck.
• Cardboard is not allowed in controlled environments because cellulose-based material is hygroscopic and can absorb moisture during humid transport or rain.
• Moisture and cardboard's organic composition can harbor environmental microorganisms, including bacterial and fungal spores.
• Mitigations include deboxing, staged material transfer, outer bag removal and sporicidal disinfectants.
• The post identifies de-boxing areas, outer packaging layers, gloved hands, carts and contact surfaces as possible vectors.
• Single-bagged configurations pose a greater challenge because folds, seams, creases and irregular surfaces may not receive full contact during manual disinfection.
• Audits should assess SOP compliance, inter-operator variability, chemistry application techniques, transfer routes, wet contact times and effectiveness under routine operating conditions.
• The post says Ecolab routinely supports facilities in evaluating material transfer practices, disinfection workflows and contamination control effectiveness.

For brands planning a campaign

A practical entry point for brands selling contamination-control services, disinfection chemistry or audit programs. A campaign can make material transfer auditing a concrete offer instead of relying on abstract cleanroom claims.

The post highlights ICH Q9(R1)'s guidance that quality risk management should consider not only product quality but also the potential impact of supply interruptions on patients.

• ICH Q9(R1) identifies process variability, facility infrastructure, and outsourced products and services as factors that may affect product availability.
• The post asks whether an aseptic manufacturer's contamination control strategy is resilient if its cleanroom chemistry supplier is disrupted.
• It argues that supplier qualification is both a compliance activity and an effective risk management strategy.
• Qualifying an alternate sanitizer, disinfectant or sporicidal chemistry supplier before an emergency can strengthen business continuity and help ensure uninterrupted access to critical contamination-control chemistries.

For brands planning a campaign

Supports a campaign on supply resilience and dual sourcing for critical cleanroom chemistries, with relevance to quality and procurement audiences as well as microbiology teams.

The post shows how total cost of ownership can shape the decision.

The post recalls first seeing a BSC used as a critical zone barrier for clinical manufacturing and struggling to reconcile the risk.

• Cody Glisson says the difficulty came from not yet understanding 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 a factor.
• The post asks whether facilities choosing between a BSC and an isolator in those areas weigh a BSC's lower upfront cost against its total cost of ownership.
• Costs and burdens to consider include higher cleanroom build requirements, increased HVAC demand and maintenance, gowning and cleaning material costs, more intensive environmental monitoring and investigations, and greater reliance on manual controls.
• It closes by asking what others have observed.

For brands planning a campaign

Useful for an equipment or facility-design campaign that wants to shift the discussion from purchase price to total cost and contamination-control burden. The post invites peer discussion rather than making a hard sell.

The post summarizes the 2026 DeFacto Biobeat Report.

• Key takeaways: AI and predictive modeling are transforming drug development while siphoning venture capital away from biotech; oncology leads innovation, with nearly 40% of drugs in development, while obesity therapeutics expand rapidly; China's biotech boom and US manufacturing reshoring are reshaping the industry; and M&A and licensing are fueling biotech progress as traditional funding tightens.
• The post questions the quality of some comparative data points on page 14.
• It also says predictive modeling's ability to unlock more traditional funding will depend on the quality of data provided, such as pitch decks and R&D information.

For brands planning a campaign

Less directly tied to aseptic operations, this post can support a general biopharma trends campaign or a discussion of data quality in AI-driven discovery. It provides secondary context rather than core evidence for a contamination-control brief.

KT forces teams to define what, where, when, and to what extent controls may have failed, separating facts from assumptions.

• Overlaying KT “Is / Is Not” analysis on a process map helps investigators spot differences between successful and failed controls and align QA, manufacturing, microbiology, engineering, and validation around one evidence set.
• Glisson warns against stopping at operator error, environmental monitoring excursions, or procedural non-compliance, because APS failures are often multifactorial.
• Practical steps include strengthening process maps with actual observations and batch records; covering all sterilization or filtration steps, routine and non-routine interventions, material transfers, glove manipulations, equipment adjustments, and line stoppages; looking at where contamination did not occur; relying on verifiable evidence such as FIT results, sterilization records, video review, intervention logs, and EM/personnel monitoring; and avoiding a premature single root cause.

For brands planning a campaign

Campaigns aimed at pharmaceutical QA, manufacturing, and microbiology teams can present this KT-plus-process-mapping method as a practical alternative to conventional deviation handling. Sponsors selling investigation training, consultancy, or contamination-control software could build a guide or workshop around the steps and evidence types Glisson lists.

Examples: Source 1 · Source 2

Cardboard is hygroscopic, and its moisture and organic composition can harbor bacteria and fungal spores.

• Even when primary materials are sterilized, they often travel through complex logistics and environmental conditions in corrugated packaging.
• Mitigations include deboxing processes, staged material transfer, outer bag removal, and sporicidal disinfectants.
• The transfer process itself can become a vector through de-boxing areas, outer packaging layers, gloved hands, carts, and contact surfaces.
• Single-bagged configurations are harder to manage because folds, seams, and creases may not receive full contact during manual disinfection.
• Results depend on operator technique, contact time, coverage, and procedural adherence.
• Audits should examine inter-operator variability, chemistry application techniques, transfer routes, wet contact times, and effectiveness under routine conditions—not just SOP compliance.
• Glisson notes that third-party observational audits can add assurance when internal resources are limited, and the post names Ecolab as routinely supporting facilities with material transfer, disinfection processes, and contamination-control evaluations.

Audit the transfer process as executed: observe inter-operator variability, disinfectant application, transfer routes, wet contact times, and routine effectiveness—not just SOP compliance.

A material transfer process that looks compliant in an SOP or contamination control strategy may still introduce unnecessary risk if execution is inconsistent.

For brands planning a campaign

This source material suits campaigns for cleanroom consumables, disinfectants, and audit services. Brands can build content around transfer-route audits, deboxing controls, and the limits of single-bag disinfection, using the wet-cardboard example as a plain-language hook.

Examples: Source 1

The post focuses on how the event is perceived.

• Treating a positive as evidence that the process or personnel are incapable can encourage avoidance, silence, blame, and fear—all of which work against the investigation and future quality.
• Glisson argues that framing the failure as an improvement opportunity supports learning, sharing, proactive observation sharing, and empowerment, while preserving the scrutiny and urgency needed to protect patients and reinforce standards.

For brands planning a campaign

A quality-culture, contamination-control, or investigation-training campaign can address the human side of an APS failure. Messaging that reduces blame and promotes structured learning may resonate with quality leaders while keeping patient safety and urgency in view.

Examples: Source 1

For aseptic manufacturers, the practical question is whether their contamination-control program depends on qualified cleaning and disinfection chemistries from a single supplier. Glisson treats supplier qualification as a risk-management activity, not just compliance, and suggests qualifying an alternate sanitizer, disinfectant, or sporicidal chemistry supplier before an emergency to strengthen business continuity.

For brands planning a campaign

Chemical suppliers, CDMOs, and procurement advisory brands can use this angle to promote dual-source qualification and business-continuity planning for disinfection programs. The link to ICH Q9(R1) gives the campaign a regulatory hook.

Examples: Source 1

In support areas for component and material preparation or staging, that uncertainty is less of a factor. The post asks whether facilities choosing between a BSC and an isolator in those areas weigh the lower upfront BSC cost against total cost of ownership: higher cleanroom build requirements, increased HVAC demand and maintenance, gowning and cleaning material costs, more intensive environmental monitoring and investigations, and greater reliance on manual controls.

For brands planning a campaign

Equipment vendors, engineering firms, and facility-planning consultants can build content around total cost of ownership for BSC and isolator choices, especially the monitoring and investigation burden buyers may underprice.

Examples: Source 1

They are hopeful that predictive modeling could unlock more traditional funding, but say that depends on the quality of data in pitch decks and R&D. They also question the comparative data points on page 14 of the report.

For brands planning a campaign

For biopharma data, analytics, or partnering platforms, data quality offers a campaign angle on funding decisions. In contamination-control or aseptic-manufacturing briefs, it can provide broader industry context rather than a core recommendation.

Examples: Source 1

Ask whether they have a commercial relationship with Ecolab.

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Like Glisson, Lewis connects manufacturing and quality topics to the wider commercial picture, including the acquisition of an automation and digital manufacturing business and how project delivery, CQV, quality and operations fit together across the facility lifecycle.

Lewis works mostly as a news and industry-update curator, rounding up deals, regulatory shifts and pipeline news, with occasional commentary on manufacturing integration. Glisson focuses on individual technical methods—how to run an investigation, where contamination risk enters the process—and explores them in detail rather than surveying the field.

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Mike B.'s argument that a quality management system is infrastructure for scale, with disciplined processes, risk management and corrective action, aligns with Glisson's insistence that investigations and contamination controls rest on documented, verifiable practice. Both also address people entering or moving through technical careers.

Mike B. draws on aerospace, defence and start-up manufacturing and brings in academic studies on ISO 9001 and financial performance, aiming at executives in young hardware companies. Glisson writes about regulated aseptic pharmaceutical manufacturing, where the focus is patient safety and a stalled media-fill investigation rather than growth-stage process discipline.

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They write for operations and engineering audiences and point readers to further sources.

Adavani writes about digital twins, Industry 4.0, predictive maintenance and factory scheduling—technology-led change in discrete and process manufacturing. Glisson writes about aseptic contamination control, quality culture and investigation methods, where the constraints are technique, evidence and procedure rather than data systems.

Read original · Original 2

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.

That lifecycle perspective puts less emphasis on APS investigations and contamination-control methods. For a campaign about investigating a media-fill failure, Cody’s posts offer a more specific approach: combine Kepner-Tregoe analysis with process mapping, then verify conclusions against operational evidence.

Examples: Source 1

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.

For a campaign focused on a concrete contamination-control investigation method, Cody is a closer fit than this post about quality-system practices in start-ups.

Examples: Source 1

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.

For a campaign about APS failures and the information used to investigate them, Cody is a more direct fit than this work on digital manufacturing.

Examples: Source 1 · Source 2