Global CDMO Improves Oral Solid Dose Packaging with Deterministic CCIT
Synopsis
Challenge
A global CDMO needed to replace destructive blue dye leak testing for Oral Solid Dose packaging with a faster, more compliant alternative. Evolving ASTM standards and growing customer expectations demanded a deterministic, data-driven approach.
Solution
The company implemented Sepha’s Multi-Q and VisionScan 3D systems for non-destructive testing of bottles and blister packs. Both solutions are fully aligned with ASTM standards and 21 CFR Part 11, offering precision, traceability, and minimal disruption to production.
Benefit
The move to deterministic CCIT improved efficiency, ensured regulatory readiness, reduced waste, and increased customer confidence. The success of the North American site is now shaping quality standards across the CDMO’s global network.
Improving Packaging Integrity Across OSD Lines
A global Life Sciences company with a significant Contract Development and Manufacturing Organization (CDMO) division, set out to improve its packaging integrity processes for oral solid dose (OSD) products. Driven by tightening global regulations, increasing customer expectations and internal efficiency goals, the company focused on implementing deterministic testing in line with ASTM standards.
This customer story outlines how the CDMO’s North American site proactively transitioned from traditional, destructive leak testing methods to a fully compliant, deterministic approach using Sepha’s Multi-Q and VisionScan 3D systems. This change resulted in a more efficient, audit-ready, and commercially competitive packaging operation across its OSD packaging lines.
Background
The facility plays a critical role in the CDMO’s global network, supporting high-volume production of oral solid dose forms, including tablets and capsules, packaged in both blister packs and induction-sealed bottles.
Historically, leak testing for both formats was carried out using destructive methods including blue dye ingress testing. While effective and widely accepted, these methods introduced challenges, including sample loss, operational inefficiencies, and limited data traceability.
As guidance from ASTM standards and 21 CFR Part 11 evolved, and as more customers began specifying deterministic testing as a contractual requirement, the company recognized that its quality infrastructure needed to be adjusted. What began as a response to regulatory and commercial pressures soon became a catalyst for broader operational transformation.
Defining strategic priorities
The CDMO’s leadership identified container closure integrity testing (CCIT) as a critical opportunity for improvement. The project was structured around several clear objectives:
- Achieve regulatory readiness, with full alignment to ASTM standards and 21 CFR Part 11 data integrity requirements
- Improve operational efficiency, by reducing sample waste, streamlining batch release, and eliminating manual testing bottlenecks
- Strengthen commercial positioning, by offering deterministic CCIT capabilities as part of its standard OSD service package
- Develop a Scalable Model: Create a solution applicable to other facilities across the global network.
Aligning Technology with Industry Standards
A cross-functional team from quality, production, validation and procurement reviewed multiple technology providers. A key requirement was alignment with ASTM standards and support for deterministic testing. Sepha was invited for an on-site demonstration, enabling the team to assess test precision, usability, and the performance of digital recordkeeping in a real manufacturing environment.
Following a comprehensive evaluation, Sepha was selected based on both the performance of its technology and the availability of validation, calibration, and technical support within North America.
Ensuring Reliability and Data Quality
The site integrated Sepha’s VisionScan 3D and Multi-Q systems across its OSD packaging lines.
Sepha VisionScan 3D
Used for blister pack testing, the VisionScan 3D utilizes advanced imaging and vacuum measurement to identify defects in individual blister pockets as low as 5µm.
- Compliant with ASTM F3169-16 (2024)
- Tool-less design allows for rapid product changeovers.
- Provides clear pass/fail results with automated batch documentation
- Compatible with all major foil and cavity designs.
Sepha Multi-Q
Configured for non-destructive integrity testing of induction-sealed bottles, the Multi-Q utilizes vacuum and pressure decay to detect micron-level defects without product loss.
- Aligned with ASTM F2338-24 standard test method
- Detects leaks as small as 5 microns.
- Supports 21 CFR Part 11 compliance, with audit trails, electronic signatures, and secure user access.
- Supports a variety of bottle formats through interchangeable tooling.
Both systems were incorporated into batch release processes with minimal disruption. Sepha supported the transition with comprehensive validation documentation and on-site training, allowing testing to commence promptly during production.
Delivering Value Across the Operations
The implementation of deterministic CCIT, aligned with ASTM standards, produced significant operational and commercial benefits:
- Greater batch Efficiency: Non-destructive testing enabled more frequent checks closer to the line, supporting faster batch release.
- Improved compliance posture: 21 CFR Part 11 compliance ensured secure data trails and inspection readiness, streamlining both internal and external audits.
- Higher customer confidence: The ability to meet deterministic CCIT requirements strengthened the company’s value proposition for clients in regulated markets.
- Operational Uplift: Cross-team collaboration improved, and quality oversight became more proactive, with clearer insight into packaging integrity trends.
One site leader noted, “Deterministic testing is now embedded in how we work. It’s allowed us to raise the standard for both quality and efficiency.”
Encouraged by the positive results in North America, the CDMO is now evaluating the opportunities to extend the approach to other sites within its global manufacturing network.
A Platform for Ongoing Quality Leadership
By proactively embracing deterministic, non-destructive testing aligned with ASTM standards and client needs, the CDMO transformed a core part of its quality assurance function. The introduction of Sepha’s technologies supported regulatory compliance, reduced waste, and strengthened the company’s commercial proposition for oral solid dose packaging.
Contact our team of experts today on +44(0)28 9048 4848 to learn how Sepha’s container closure integrity testing solutions can support your operations, or watch the videos below to see our technology in action: