Parenteral Packaging Innovations

April 11, 2018
Hallie Forcinio
Equipment and Processing Report
Volume 11, Issue 4

New filling and inspection machines and new containers and closures for injectable drugs will be on display at INTERPHEX 2018.

The annual INTERPHEX show remains one of the best venues to study parenteral packaging innovations and related fill/finish equipment. This year’s show (April 17–19, 2018, Javits Center, New York, NY) continues that tradition. 

Filling and inspection machines

For parenteral packaging lines, new syringe fillers meet the rising demand for prefilled syringes. Compact and flexible, the FSP 05 filling and stoppering machine from Marchesini Group for nested syringes accurately fills up to 12,000 syringes/h. Available with various dosing options, the system offers precise and gentle centering and handling, which minimize the chance of breakage (1). 

The Injecta syringe filler from IMA Life North America relies on advanced robotics to smoothly process tubs and components and limit operator access to the working area. Glass-to-glass contact is minimized, and in-line process control makes it possible to reject a single non-conforming syringe. Other features include complete accessibility and fully automatic component feeding and handling (2). 

For low-volume needs and small spaces, Cozzoli Machine offers the FSV50 Mini Monoblock machine for vials ranging from 1–100 mL. Designed for use in a cleanroom environment with hood isolation and laminar flow, the machine fills liquids or powders and applies a stopper or cap at speeds up to 50 vials/min (3).

For quality control, Antares Vision is launching an enhanced Lyo-Check inspection machine for lyophilized (freeze-dried) products. Dedicated software and optical layout support the system’s vision architecture. “We believe the machine will have a significant impact on the lyophilized product sector in terms of prolonged storage possibilities, higher product quality due to improved inspection, and lower process costs compared to manual inspection,” said Davide Sacchetti, business development manager for Inspection Machines at Antares Vision, in a press release (4).  

Containers and closures

The Matrix Alliance, which is made up of packaging and component suppliers, performs testing to provide pre-validated container/closure solutions for Vanrx Pharmasystems Aseptic Filling Workcells. The Alliance aims to ensure the compatibility of components from different members and publicize the advantages of ready-to-fill technology (5). 

Testing performed by the Alliance has confirmed compatibility of ready-to-use container and closure product sets with the Microcell Vial Filler and SA 25 Aseptic Filling Workcell from Vanrx Pharmasystems. One commercially available product set, the Schott adaptiQ vial and ARaymondlife RayDyLyo plastic press-fit closure, assures high performance and enables faster market introductions of sterile injectables, according to a press release (6). RayDyLyo plastic press-fit caps stopper and seal containers in one step, replacing aluminum crimp caps and eliminating associated risks related to particles. Current offerings include standard 6R and 10R vials and corresponding 20-mm press-fit closures. 

Another compatible product set, the Ompi EZ-fill vial and Daikyo Seiko Plascap press-fit elastomeric/plastic closure, offer similar advantages and are initially available in 6R, 8R, and 10R vials and corresponding 20-mm press-fit closures (7).

Other confirmed combinations include Schott Kaisha 1-mL long syringes and its nested syringe stoppers in 100- and 160-unit-per-nest configurations, and the company’s 3-mL cartridges and its nested cartridge stoppers in a 100-unit-per-nest configuration (8). 

In other container news, SGD Pharma plans to introduce its Clareo premium range of molded Type II glass vials. A controlled manufacturing process results in homogeneous wall thickness, superior cosmetic quality, improved mechanical resistance to shock, reduced breakage rate, and easier pre- and post-filling inspection. Flatter, more uniform bottoms ease thermal transfer during freeze-drying. With characteristics similar to existing vials, the transition to a Clareo vial requires no regulatory change. In some cases, the vials offer a lower cost option to Type I glass vials. The company offers Clareo Type II vials in 20-, 50-, and 100-mL sizes, with additional sizes under development, and can produce the containers in Type III glass (9). 

References

1. Marchesini, “INTERPHEX 2018, the Marchesini Group Focuses on Aseptic Packaging and Cosmetic Packaging Markets,” Press Release, Feb. 26, 2018.  

2. IMA Group, “The IMA Group at INTERPHEX 2018, Discover IMA’s Innovation!,” Press Release, Feb. 26, 2018. 

3. Cozzoli Machine Co., “Cozzoli Machine Company to Exhibit at INTERPHEX 2018,” Press Release, March 5, 2018. 

4. Antares Vision, “At INTERPHEX NYC, Antares Vision to Debut Enhanced Lyo-Check Machine for Lyophilized Products, and Showcase ATS Four Serialization Software,” Press Release, March 12, 2018. 

5. Vanrx Pharmasystems, “Pharmaceutical Packaging Industry Leaders Form the Matrix Alliance to Help Manufacturers Speed Breakthrough Treatments to Market,” Press Release, Feb. 15, 2016. 

6. Vanrx Pharmasystems, “Schott AG, ARaymondlife and Vanrx Pharmasystems Announce Product Compatibility for Primary Packaging of Sterile Injectables,” Press Release, Feb. 7, 2018. 

7. Vanrx Pharmasystems, “Vanrx Pharmasystems Announces Compatibility between Ompi EZ-fill vials, Daikyo Seiko Plascap Press-fit Closures and Aseptic Filling Workcells for Primary Pharmaceutical Packaging,” Press Release, Feb. 7, 2018.

8. Vanrx Pharmasystems, “Schott Kaisha and Vanrx Pharmasystems Announce Product Compatibility for Primary Packaging of Sterile Injectables,” Press Release, March 13, 2018. 

9. SGD Pharma, “SGD Pharma Introduces Its New Clareo Range,” www.sgd-pharma.com/company-news/sgd-pharma-introduces-its-new-clareo-range, accessed March 26, 2018.