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Equipment and Processing Report
INTERPHEX 2017 exhibitors focus on shelf life, traceability, and quality control.
Many packaging technologies help pharmaceutical manufacturers deliver the highest quality product to the caregiver or patient, and several quality-enhancing technologies can be found at INTERPHEX 2017 (March 21-23, Javits Center, New York). With the Drug Supply Chain Security Act’s (DSCSA) serialization deadline rapidly approaching, many exhibitors are emphasizing serialization expertise and support for traceability from manufacturer to patient. Other exhibitors are focusing on quality control, new ways to maintain shelf life, temperature management throughout the supply chain, and package integrity.
PTI Inspection Systems will non-destructively test blister pack samples brought by visitors to demonstrate its VeriPac UBV universal blister package leak detection system. The VeriPac UBV tester relies on volumetric imaging under vacuum to detect the presence of leaks in multi-cavity blister packs in a three-step process. At the end of the test, the unit presents a definitive pass/fail result, a volumetric measurement reading, and the location of any defective cavity. Defects as small as 10 microns can be located during a test cycle lasting less than 15 seconds. Changeover to a different blister requires no tools or test parameter changes.
The PharmaFlex iSeries 750 CE DT dust-tight deduster from Pharma Technology not only dedusts solid dosage forms, but also ensures product quality with an integrated metal detector and tablet tester (weight, thickness, hardness). Enlarged tablet inlet and outlet ports boost output (>1 million/h with 12-mm tablets). To expedite changeover, the spiral tower can be replaced with a clean unit of the same or different height in less than three minutes.
Maximum product quality also is the goal of the high-resolution, laser-based Lynx-Spectra 3D image processing system from Scanware. It inspects the geometry of packaging material and products to detect distortions, dents, and other defects to prevent faulty products from moving into the supply chain.
When products must be maintained within a specific temperature range, TempEZ temperature management software from Almac Group provides an always-accessible database of temperature readings. The web-based, good distribution practice-compliant platform provides complete visibility of temperature compliance for any commercial or clinical drug product throughout its journey from manufacturer to patient administration. Compatible with any monitor and any logistics provider, the software builds a complete temperature history at lot and serialized levels to ensure regulatory compliance and safeguard product. At the same time, Almac’s global Temperature Management team can provide support services related to compliance, excursion adjudication, and lifecycle management.
To maximize product stability and shelf life, Activ-Seal closures from CSP Technologies build gas-scavenging technology into an induction-sealed, tamper-evident screw cap. The gas scavenger controls levels of moisture and volatile off-gases. An orifice-reducing element is affixed to the top of the bottle during the induction sealing process. It is covered by a lift-and-peel foil seal, which, once removed, enables metered dosing. The scavenging component, tailored for moisture, volatile organic compounds, and/or odor management, is permanently positioned on the underside of the orifice reducer. The integrated scavenger/closure eliminates insertion of scavenging canisters or sachets and the risk of loss or accidental ingestion. Caps are available in standard sizes and can be applied on standard capping and induction sealing systems.
Delamination issues, which have prompted many recalls in recent years, have been overcome with the high chemical durability of Schott Vials Delamination Controlled (DC). In storage studies with 15% potassium chloride, 10% sodium thiosulfate, ultrapure water, citrate buffer, phosphate buffer, sodium bicarbonate buffer, and ethylenediaminetetraacetic acid, the vials remained stable, and no glass delamination was observed. Because the vials are based on established hot-forming principles without any additional post-process steps, no reregistration is needed when replacing packaging being used with approved drugs. The vials are available in ISO sizes 2R to 10R, but larger sizes (e.g., 50 mL) have also been produced.