New 18 mm Child-Resistant Closure for Nasal Products Containing Imidazolines

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Comar SecureCap® closures offer a fast-track to compliance for manufacturers of eye drops and nasal sprays that require child-resistant packaging.

…it was apparent from the public comments that some of the companies would have to incorporate child-resistant closures in aseptic filling lines, which could cause delays. We’re prepared to help.

Comar LLC, a leading manufacturer of innovative dosing and dispensing devices, announced the availability of 18 mm SecureCap® Child-Resistant Closures. The closures are part of a growing product line designed to safely package and dispense eye drops and nasal sprays containing 0.08 milligrams or more of imidazolines, products that require child safe packaging by the Consumer Product Safety Commission (CPSC). SecureCap® Closures feature a two-piece push and turn technology patented by Comar for effective child-resistant and senior-friendly performance. The 18 mm SecureCap® Child-Resistant Closure is available from Comar immediately and technical staff are prepared to work with manufacturers and packagers to assist them in complying with CPSC regulations.

On December 10, 2012, the CPSC issued a rule requiring special packaging for over the counter and prescription products containing 0.08 milligrams or more of a specified imidazoline (tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a single package, and producers were given one year to comply. In consideration of concerns raised by the rule, the CPSC extended the deadline to December 10, 2014. Of 17 firms manufacturing products covered by the rule, 4 companies reported to the CPSC that the approved, child-resistant packaging would be available by the end of 2014. Reporting production-related delays and failures, another 8 manufacturers requested additional time. On November 14, 2014, the CPSC announced another stay of enforcement and a new deadline for compliance of June 10, 2015.*

Comar SecureCap® Child-Resistant Closures are commercially available. The closures meet CPSC Protocol 16 CFR 1700.2 for child-resistant packaging. Designed to accommodate industry-standard finishes on plastic dropper bottles and metered dose sprayers, Comar SecureCap® can be used with existing materials minimizing a manufacturer’s need for stability testing. Additionally, closures can be applied using existing capping equipment on most filling lines, reducing the time and costs for customers to transition to approved packaging.

“We reviewed this and previous CPSC announcements very carefully, and it was apparent from the public comments that some of the companies would have to incorporate child-resistant closures in aseptic filling lines, which could cause delays,” says Michael Ruggieri, CEO of Comar. “We’re prepared to help.”

In addition to the new 18 mm closure, Comar introduced a 15 mm SecureCap® closure in 2014, which can be used with existing bottles or combined with Comar bottles and dropper tips to provide a complete packaging solution. SecureCap® closures are also available in custom sizes and configurations.

Comar SecureCap® products are manufactured in facilities that comply with current Good Manufacturing Practices (cGMP) and ISO 9001:2008 and ISO13485 quality standards. For additional information or samples, please call: 1-856-507-5409, email: marketing(at)comar(dot)com, or visit http://www.comar.com/securecap.

About Comar
Comar, LLC, a company defined by its devotion to quality, service and innovation, is a leading manufacturer of plastic dosing and dispensing products, bottles, containers and closures. We provide a global customer base in health and wellness, specialty food, household and light industrial markets with a broad array of proprietary products, custom molding, printing and complex assembly capabilities. Our expertise with all the major rigid plastic processing platforms, including injection molding, extrusion blow molding, injection blow molding and injection stretch blow molding, is available from six North American manufacturing facilities. For a safe, innovative solution to containing and delivering your high value product, come to Comar. Visit our website for more information: http://www.comar.com.

  • FR Doc. 2014-27378 Filed 11-19-14; 8:45 am

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LouAnn Evans
Comar, LLC
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