Maximizing Quality in Pharmaceutical Packaging

Product protection took many forms at this year’s INTERPHEX (April 17–19, 2018, Javits Center, New York, NY). Innovations in fill/finish systems included robotic systems to minimize human intervention. In solid-dosage drug packaging, several companies exhibited desiccants and other technologies for extending shelf-life.

Fill/finish systems

Two fill/finish systems captured 2018 INTERPHEX Exhibitor Awards. The Best in Show Award recognized the Microcell vial filler from Vanrx Pharmasystems. The completely robotic aseptic filling machine, built within gloveless isolators, performs repeatable and precise fills for drug development, early clinical trial supplies, and manufacturing of autologous cell therapies, gene therapies, immuno-oncology products, and other personalized medicines. 

A system for ready-to-use vials, cartridges, and syringes, the FlexPro50 from groninger USA, earned the Biotech Innovation Award. This modular, manual, or automated filling and closing system minimizes human intervention. Additional flexibility is provided by exchangeable trolleys for handling vials in trays or in bulk. A direct injection system cuts decontamination cycle time in half. 

Another notable fill/finish system, the FSM machine from Colanar, fills, stoppers, and caps nested vials and can be configured with single or dual stations, which are rated at 30 vials/min each. Compatible with single-use bags, filters, tubing sets, and filling needles, the unit offers multiple pump options and positions the control cabinet in the base. With installation of change parts, the machine can handle syringes, cartridges, and micro-vials.

The Genisys 10-20 filling and closing machine from AST also handles nested vials, syringes, or cartridges. Integrated nozzles provide inert gas purging before and after filling and during the stoppering process. In-process fill-weight verification ensures accurate fills. Options include laminar airflow hood, restricted access barrier system, or isolator. 

Italy’s Steriline, which offers a broad range of fill/finish equipment, isolators, and accessories, displayed the RTDS2 robotic tub decontaminating system. Installed as a standalone unit or between debagging and filling, the pulsed light sterilizer achieves a 6-log reduction and can decontaminate two tubs/min. It’s currently in the validation phase. 

With many bagged products in short supply since September 2017, when Hurricane Maria caused severe damage to the infrastructure and manufacturing capacity of Puerto Rico, interest is high in equipment like the 525-526 aseptic bag filling and closing machine from Bausch Advanced Technologies. The flexible carousel system handles various bag types and fill volumes from 5 mL to 5000 mL. A tube-clamping mechanism on the robot-equipped unit prevents particle penetration into the bag. Options include gassing before, during, and after filling; radio frequency, ultrasonic, or heat sealing; and camera inspection. 

Matrix and line-scan cameras on the Innoscan system from Stevenato Group Engineering Systems confirm syringe plunger position and orientation and check for particle contamination. Handling by four delta robots ensures no glass-to-glass contact even at the system’s maximum speed of more than 600 syringes/min. Integrated high-voltage leak detection identifies any faulty syringes.

Micro-current, high-voltage leak detection locates openings as small as 5 microns in vials, syringes, and containers for protein products and water for injection. The lower voltage prevents damage to product or container and generates such a small amount of ozone that no ozone filter is needed. Capable of checking one tray (160 syringes) in less than three minutes, the online E-Scan 665 tester from PTI–Packaging Technologies & Inspection relies on a six-axis robot to pick each row, place it in the test position, and return good product to the nest and faulty product to a reject tray. An off-line system, the E-Scan 655 model, also is available. 

Extending shelf-life for solid-dosage drugs

Desiccants, oxygen absorbers, and other scavenging technologies are shrinking in size or being integrated into packaging materials. Desiccare offers a narrow pouch containing molecular sieve, carbon, silica gel, or 50/50 silica gel/carbon moisture absorbers plus equipment to automate its dispensing into 30-cc or 60-cc bottles or stick packs. 

A compressed, solid-form design from Multiform Technologies eliminates the pouch or high-density polyethylene canister needed to contain traditional loose-fill desiccant. In addition to providing source reduction, the solid form packs two grams of capacity into the size of a conventional one-gram moisture controller. Currently available in white and one-, two-, or three-gram capacities, color could be added to maximize visibility. 

For products that require a specific humidity, RH Stabilizers from Clariant Healthcare Packaging maintain equilibrium relative humidity levels from 10–30% inside the package. Applications include dry powder inhalers and soft gelatin capsules. Options include packet, canister, or stopper form. 

A moisture absorber is built into a multi-dose dry powder inhaler (DPI) designed by CSP Technologies in conjunction with Simplified Solutions Sweden. In the smaller, 12-mm-wide XHaler unit,  the desiccant is mixed into the polymer material used to make the DPI device. Currently undergoing validation, the XHaler DPI depends on a patented, no-piercing technique to open the seal covering the dose to be inhaled. Eliminating piercing prevents generation of product-contaminating debris. The opening method also ensures the dose is fully loaded before the user inhales. 

About the author

Hallie Forcinio is the Packaging Editor for Pharmaceutical Technology.