	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. 

	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).  

	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). 

	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

Articles

Feature

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

Parenteral Packaging Innovations

	Tracelink recently released results of its latest Drug Supply, Safety, and Traceability Report, which looks at how effectively the links within the pharmaceutical supply chain-pharmaceutical manufacturers and contract manufacturing organizations (CMO) and distributors-are implementing serialization and traceability programs (1). Because 2018 is the last year that companies have to meet serialization requirements set by the US Drug Supply Chain Safety Act (DSCSA), the report’s findings were somewhat unsettling. “Despite goodwill efforts by industry and regulators to meet compliance on time, the industry is extremely behind in being ready for serialization,” wrote Tracelink’s CEO Shabbir Dahod in the report’s introduction. 

	Analyzing survey responses from 660 pharmaceutical companies, CMOs, wholesale distributors, hospitals, and pharmacies, the study found that only one-third are confident that they are ready to meet serialization requirements set by the DSCSA and the EU Falsified Medicines Directive. 

	In addition, none of the respondents had finished all the groundwork required for serialization. Only half of the pharmaceutical manufacturers and CMOs, for example, had prepared their internal packaging lines for serialization or projected the number of units to be serialized annually, wrote Dahod. 

	The readiness gap between pharmaceutical manufacturers and CMOs appears to be “staggering,” Dahod noted. “Pharmaceutical companies are troubled about connectivity to their CMO partners, while CMOs appear to be overstating their actual serialization readiness,” he wrote.

	Of the 660 respondents to the survey, 174 were from pharmaceutical manufacturers; 155 were from CMOs; 50 from wholesaler distributors; 195 from hospitals; 75 from pharmacies; and 11 from third-party logistics companies.  Of the pharma company respondents, 32% were at director level and 25% at manager level.  

	Of the 146 respondents from pharmaceutical companies that must meet DSCSA requirements, only one third said they felt very ready. 90% had prepared for master data management; 80% said they will be shipping serialized product by the deadline, and 72% felt confident that they understand the legal requirements behind the DSCSA and European Union Falsified Medicine Directive regulations.  In addition, 62% say their organizations began preparing for serialization 13 months before the deadline; 55% say they will use the proper electronic forms; and 55% say they have estimated the number of units that will be serialized each year. Another 51% plan to eliminate 81–100% of paper forms by November 2018.

	However, at this point, only 8% had integrated serialization processes with their CMOs, and only 11% said their CMOs were ready to ship serialized product, while only 12% said they had ordered and installed the equipment required for serialization on their internal packaging lines.  As a result, the study says, only 25% of respondents whose companies must meet requirements by November 2018 are ready for serialization and have taken the necessary foundational steps. 

	The survey found that half of all pharma CMOs felt very ready and have taken the basic steps required for serialization.  For European pharmaceutical companies and CMOs, one third of respondents said they felt very ready for serialization requirements.  13% of respondents said that most CMOs were ready to ship serialized product and 46% said that internal packaging lines had been readied for serialization. In addition, 94% of respondents from this group say they have begun preparing for master data management; 54% have projected the number of units that will need to be serialized, while 48% said they have integrated serialization efforts with their pharmaceutical company clients. However, the research found, only 15% within this group were found to be on the true path to readiness, suggesting that more work and more coordination will be needed this year.

	The study found that pharmaceutical companies had hired more staff in 2017 to help with serialization efforts, with 21% of respondents saying that they had hired or were planning to hire more staff. In 2016, only 9% responded that way.


	Tracelink’s research also found that aggregation efforts were in full swing; nearly 75% of respondents from those pharmaceutical manufacturers and CMOs that must meet DSCSA requirements had already begun to aggregate product or were planning to implement aggregation by the November serialization deadline. Within that group, 20% of pharmaceutical companies and 31% of CMOs reported that they were already aggregating product, while 33% of pharma respondents and 20% of CMO respondents said they would be aggregating by November 2018.  

	Tracelink’s study also found a disconnect between the pharmaceutical manufacturing and distributors in the chain. 60% of wholesalers who responded to the survey said they are requesting that their pharma partners aggregate product, yet one third of pharma company respondents said that their trade partners haven’t been asking for aggregation yet.

		Tracelink, “Drug Supply, Safety, and Traceability Report,” (April 2018).

INTERPHEX session on serialization and blockchain

INTERPHEX Keynote Series: Information Technology Trends and Best Practices for blockchain technology and serialization 

to be held on Wednesday, April 18, 2018. The series includes a 1:30 pm session on the industrial internet of things, blockchain, and smart contracts and a 2:15 pm presentation on serialization. The sessions will be held on the show floor at the Innovation Stage and are open to all show attendees.

Most pharma companies still aren’t ready for serialization, and only a few have coordinated traceability efforts with their CMOs, according to Tracelink’s latest readiness report.

Equipment and Processing Report-04-11-2018

Parenteral Packaging Innovations

Serialization: So Close and Yet So Far