Contract packaging
Easy-to-clean, multitrip aluminum pallets from LM Containers can be customized to user specifications. (COURTESY OF LM CONTAINERS.)
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Drugmakers seeking contract packaging services had many exhibitors to visit. One new 30,000-ft2 facility offers aseptic vial filling and manufacturing that complies with current good manufacturing practices (CGMPs),
plus a development area with multiple manufacturing and containment suites. The aseptic vial-filling line is designed to fill
containment and high-potency products and will initially focus on filling small-molecule drugs. Designed for clinical supplies
and niche commercial manufacturing, the operation includes a qualified, 60-ft2 lyophilizer (Beaver Court complex, Pharmaceutics International, Hunt Valley, MD).
Productivity-enhancing tools
A stainless-steel accumulator–single filer moves small vials at rates faster than 800 vials/min. The patented conveying system
handles vials as small as 2 mL with virtually no back pressure ("Infinity Rx" accumulator–single filer, Garvey, Blue Anchor, NJ).
Life cycle management software manages each step of a label's lifespan, including design, review, approval, printing, updates,
revisions, and obsolescence across multisite operations. Software is compatible with barcode and radio-frequency identification
labels and provides the comprehensive security and audit logs required for compliance with 21 CFR Part 11. An XML interface enables seamless integration with enterprise resource planning, product life cycle management and
other enterprise systems ("ROBAR Enterprise Label Management System," Innovatum, Sugar Hill, GA).
Stainless-steel operator interface mountings improve efficiency, ease of use, and cleanability in sensitive pharmaceutical
environments. Tightly integrated display and keyboard enclosures feature an industry-standard articulating arm for counterbalanced
vertical adjustment and ergonomic flexibility. Durability and superior construction reduce data inaccuracies and unnecessary
downtime ("MiniStations" operator interface mounting system, Strongarm Designs, Horsham, PA).
"EQPac" software from Mettler-Toledo Hi-Speed expedites checkweigher qualification. (PHOTO: COURTESY OF METTLER-TOLEDO HI-SPEED.)
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Statistical quality-control software for the packaging process integrates checkweighers, metal detectors, statistical balances,
and other data-collection devices into a network. Test stations also can be established to measure and record product attributes
such as cap torque, label placement, and lot numbers to unify all aspects of the quality process in one program. Extensive
report and dashboard capabilities simplify the monitoring of important functions. An audit-trail module helps meet the requirements
of 21 CFR Part 11 for electronic signatures, data management, and traceability. The program also can be provided with a full set of
validation protocols to ensure CGMP-compliant monitoring ("FreeWeigh.Net" software, Mettler-Toledo Hi-Speed, Ithaca, NY).
Software also can help expedite the equipment-qualification process. A fully documented process for checkweighers, for example,
adheres to good testing and good documentation practices to deliver accuracy and consistency ("EQPac" software, Mettler Toledo
Hi-Speed).
Product protection
Tablets and capsules are printed in a programmable, noncontact process to provide a readily visible, pill-level method of
product identification and differentiation. The 12-lane system relies on an inkjet printer and pharmaceutical-grade black
ink. A vision system provides 100% inspection ("EAM Tablet/Capsule Printing Machine," Efficient Automated Machine, Long Island City, NY, "Industrial Print System," Inc.Jet, Norwich, CT; "Pharma Black Ink," HP, Palo Alto, CA).
Machine-readable covert codes serve as a product-authentication tool and help prevent counterfeiting and diversion. Two-dimensional
barcodes carry item or batch-level information and can be printed by existing equipment. Resulting codes are invisible to
the naked eye and under ultraviolet light but are readily identified with an easy-to-use, handheld reader ("TrackSure" technology,
Inksure Technologies, Fort Lauderdale, FL.)
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