Almac Pharma Services Case Study: Weight Sorting Validation for R&D Capsule and Tablet Batches

Validation for R&D capsule and tablet batches is essential for pharmaceutical CDMOs managing variable formats, batch sizes, and accelerated timelines. As a result, Almac Pharma Services required a consistent, compliant method to inspect and record capsule and tablet weights during early-phase development to protect QA standards and data integrity. Almac Pharma Services is an FDA- and MHRA-approved contract development and manufacturing organisation (CDMO) operating across the UK and Europe. Its R&D teams manage diverse dosage forms, rapid formulation changes, and short project turnaround times, making regulatory compliance, operational efficiency, and traceable QA processes critical to every client engagement.

Project Requirements

To strengthen validation for R&D capsule and tablet batches, Almac Pharma Services needed a flexible, compliant, and efficient solution. The company manages frequent client transitions, variable batch sizes, and rapid formulation changes across its R&D operations.

Therefore, the selected system had to:

Support accurate weight sorting of both capsules and tablets
Handle batch sizes ranging from 1,000 to 250,000 units
Operate without product-specific change parts, allowing fast changeovers
Reduce manual handling to lower the risk of operator error
Maintain full QA documentation to support regulatory compliance

Because R&D timelines are often compressed, repeatability and speed were essential for maintaining throughput and client satisfaction.

The CI Precision Solution

To meet these needs, Almac implemented the SADE SP140 and SP440 weight sorters from CI Precision. These systems were chosen for their ability to deliver high-accuracy weight sorting without the need for format-specific tooling.

As a result, Almac could:

Switch quickly between projects with minimal setup time
Accurately sort capsules and tablets across flexible batch sizes
Reduce manual intervention and standardise QA outcomes
Improve lab efficiency while ensuring data integrity

Additionally, CI Precision supplied:

Validation documentation aligned with GMP requirements
Spares packs for ongoing uptime
Licensing and service support to ensure long-term system performance

Consequently, Almac achieved faster project turnaround, improved compliance, and scalable QA capability across its R&D division.

Key Project Stats:

Key R&D Validation Stats Application: Weight sorting validation for R&D capsule and tablet batches Batch size range: 1,000 to 250,000 units Dosage forms: Capsules and tablets Weight sorting systems: SADE SP140 and SP440 Change parts required: None for product changeover Primary benefit: Rapid changeovers across multiple client projects QA support: Validation documentation and GMP alignment Operational support: Service, calibration, spares, and repair Partnership duration: Nearly 20 years with CI Precision

"SADE equipment is used by our Clinical Services Division. They recommended CI Precision to us and we now have a SADE SP140 and a SP440 in Pharma Services"

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