HIGH POTENCY APIS methods and the outcome systematically evaluated to support changeover decisions, including the assessment of actual carryover versus a scientifically derived maximum allowable carry-over.
In addition, manufacturing areas should be released for subsequent operations only after formal lineclearance procedures have been completed. These include analytical verifications( e. g. swab sampling of surfaces) to confirm that residual contamination levels are within predefined acceptance criteria and that exposure and crosscontamination risks are effectively controlled.
Safety culture
Operational controls should be reinforced through a strong culture of safety and learning. Incident and near-miss reporting must be actively encouraged, enabling timely corrective and preventive actions and supporting organisational learning through trend analysis. Regular task risk assessments should be performed and refreshed to reflect operational experience, resulting in continuous improvement of procedures, work instructions and training content.
Detail of glovebox under filter-dryer
This closed-loop approach helps ensure operational controls remain current, practical and effective as processes and products evolve. Customer feedback shows that this is an area where Ajinomoto Bio Services is clearly differentiated from its competitors.
PPE requirements are defined through a structured, task-specific assessment considering the assigned OEB, the nature of the activity, the effectiveness of primary and secondary containment and potential non-routine scenarios, such as maintenance or upset conditions. This approach ensures consistent, risk-based application of PPE while supporting reliable operator protection.
Verified performance
Engineered containment solutions alone do not guarantee effective exposure control. The effectiveness of a containment strategy is determined by its ability to achieve the required performance under representative operational conditions.
Containment performance should be verified using the standardised SMEPAC methodology, enabling quantitative evaluation of airborne particulate emissions and surface contamination against predefined targets. It is systematically verified for each new containment strategy as an integral component of the qualification process and is reevaluated following significant modification to ensure continued compliance with predefined performance targets.
At Ajinomoto, for example, SMEPACbased containment performance verification is conducted in-house under the oversight of the EHS department. Testing is performed under actual process conditions and executed by trained operational personnel to generate representative results. Thus, it includes the full process context, including operator interactions. In alignment with a lifecycle approach, cleaning and changeover activities are explicitly included within the scope of performance verification.
The outcomes of these evaluations provide objective results to confirm that containment systems and associated operating practices perform as intended and a basis for the continuous optimisation of engineering. In accordance with the hierarchy of controls, the effectiveness of the containment strategy is evaluated independently of PPE, which remains a supplementary measure for the mitigation of residual risk.
Ongoing assurance of worker protection is further supported through a structured occupational health surveillance programme, including periodic medical evaluations. This additional layer of verification helps confirm that the integrated containment strategy continues to perform as intended, ensuring sustained protection of personnel over time. ●
Joris de Keiser
STRATEGIC MARKETING MANAGER
AJINOMOTO BIOPHARMA SERVICES
J j
Ajinomoto Omnichem joris. dekeijser @ aoc. ajinomoto. com
JUL / AUG 2026 SPECCHEMONLINE. COM
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