Sigpack Systems

Sigpack Systems has enabled Dey, L.P to meet new FDA regulations. A new packaging system allows it to provide clients with individually wrapped unit dose vials, containing both the lot number and the expiration date. The new system has also achieved substantial material savings - making up for the difference in line cost in the first four months of use.

Sigpack Systems' pharmaceutical clients must abide by and, in many cases, be one step ahead of FDA mandates. One industry leader, Dey, L.P. of Napa, California, realized that, the FDA was on the verge of coming out with a new regulation, whereby all unit doses must be individually packaged with bar code and expiration date. Having always been a leader in the respiratory field, Dey wanted to provide its customers and patients with the highest degree of safety and assurance that the product they are receiving is what their doctor prescribed.

Dey’s existing packaging operation produced cards of five blow-fill-seal type vials. The company is highly adept at the packaging of cards of five vials, both at high speed and large volumes, and had never packaged individual vials. Single overwrapped vials became necessary to satisfy its hospital customer needs. Dey quickly recognized that it would need the experience of a company which had met similar challenges and that had the ability to integrate an entire high-speed line. The new packaging would also need to satisfy the FDA requirements without reducing throughput.

To achieve this, Dey called in the help of Sigpack Systems. “There were several factors that went into this decision,” explained Gary L. Michaud, senior vice president of operations at Dey. “Among those factors were the need for a single source for the entire line; packaging design that used the least amount of foil for the overwrap; the favorable delivery schedule; and Sigpack Systems having an excellent name in the industry for quality.”

Having the highest speed wrappers on the market allowed it to achieve the necessary output required, yet maintain current production levels. By offering a complete system solution Sigpack Systems was able to provide Dey with both high output and equally importantly, total system reliability.

A common operator interface is used throughout the system. The consistent screens and logic result in more efficient operator and maintenance training and enables individuals to operate the entire system. Software lockout prevents validation or traceability being compromised.

Individual lots containing tote bins of cards, each with five vials as well as packaging materials, are brought to the packaging room. The next challenge for Sigpack Systems was to separate the vials in such a way that there would be no chance of cutting or breaking a vial to cause a leak. First a manual prototype machine was developed and the concept was then approved by Dey, which resulted in a customized vial separation and feed system. Checking the vials for damage using a vision system ensures quality.

These unit dose vials then have to be hermetically sealed in order to be hermetically wrapped at a total rate of 600 per minute. This required a two-leg system, starting at the Hoppmann bowls and continuing through the HSL wrappers. The HSL wrapper is the highest speed long-dwell sealing solution currently on the market and, at Dey, each machine wraps 300 products per minute.

For pharmaceutical packaging applications all lots and expiration dates need to be verified. To achieve this, Sigpack Systems used a Cognex vision system to verify the print on the individually wrapped unit doses, the cartons and the cases, as well as to log activity. In all instances a misprint results in rejecting the product at various points along the line.

A Sigpack Systems top loading cartoner, with integrated carton former, supports Dey’s shelf carton formats, which contain 25, 30 or 60 individually wrapped vials. The output of both wrapping legs feed into two individual collators. A robot arm with customized gripper then top loads the wrapped individual vials into the shelf cartons.

An individual leaflet is placed in each shelf carton and its presence verified prior to the shelf carton being closed. At the case loader, RSC-Cases are erected and the bottom glued with hot melt adhesive. They are then loaded from the top, with cartons in two layers, prior to being closed. The cartons are also bar coded for traceability. Finally a corner label is applied and the cases automatically palletized.

The entire packaging line can be changed over to run another format within 30 to 45 minutes, due to the limited number of change parts and the relatively easy change over procedures on all the Sigpack Systems equipment. Dey is also saving money since it now needs only three or four people to run the line per shift thanks to the reliability of this packaging system.

Sigpack Systems plays a leading role in support of its pharmaceutical users and, as the Dey, L.P. has found, helps keep clients’ finished goods supply chain safe and secure.
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