Comar offers bottle, tip and 15mm SecureCap™ closure are available for shipment to over-the-counter and prescription manufacturers of ophthalmic and nasal products
BUENA, NJ – Comar LLC, a leading supplier of children's dosing devices, announced that its SecureCap™ Child-Resistant Closure has passed the CPSC testing requirements for child-resistant (CR) packaging. The closures allow manufacturers of over-the-counter and prescription eye drops and nasal sprays containing 0.08 mg or more of imidazolines to comply with CPSC regulations requiring the use of child-resistant packaging. Comar is offering 15 millimeter SecureCap™ closures individually, or they can be combined with Comar bottles and dropper tips to provide a complete packaging solution. The SecureCap™ package has undergone United States Pharmacopeia (USP) 27 <661> testing for extractables and light transmission, USP 32 <671> container performance testing for moisture vapor transmission rates (MVTR) and CPSC Protocol Title 16 of the Code of Federal Regulations (CFR) 1700.2 for child-resistant package testing.
During the last two decades, as many as 9,000 children under 5 years old may have suffered injuries related to ingestion of an imidazoline according to the CPSC. Imidazolines are a family of drugs used as topical decongestants in eye drops and nasal products. When ingested orally imidazolines may cause serious adverse reactions, especially in young children. The CPSC reports over 80 million products containing imidazolines are sold under 65 brands to consumers annually. The effective date for requiring child-resistant packaging of products containing imidazolines is December 10, 2013. The CPSC has given manufacturers one year to comply.
SecureCap™ CR Closures are high quality child-safe and senior friendly closures. The design features a two-piece push and turn technology patented by Comar. For rapid implementation, the closures accommodate industry-standard finishes. In many cases, the design allows for the use of existing materials, minimizing a manufacturer's need for packaging stability testing. Additionally, experience thus far has shown that the closure can be applied utilizing existing capping equipment on the filling line, resulting in significantly reduced costs and time for customers to transition to the new package when compared to other alternatives. SecureCap™ closures are also available in custom sizes and configurations.
"For some OTC and prescription manufacturers, compliance with the CPSC requirement for CR packaging may result in delays and costly retooling of filling processes to accommodate new closures," says Mike Ruggieri, President and CEO of Comar. "Our SecureCap™ closures are a stocked item, and we are working closely with our customers to assist them in complying with the CPSC regulation as quickly as possible," he added.
Comar manufactures products in facilities that comply with current Good Manufacturing Practices (cGMP) and ISO 9001:13485 quality standards. For additional information or samples, please call: 1-856-507-5409, email: firstname.lastname@example.org, or visit www.comar.com/securecap.
Comar, LLC is a market leading designer and manufacturer of innovative packaging solutions and liquid dispensing products, serving Pharmaceutical, Healthcare, Personal Care, Clinical Diagnostics and related market segments. The company is a primary packaging supplier offering manufacturing services for pharmaceutical and Class 1 medical device molding of dosage delivery systems. Comar is devoted to safely and accurately delivering medications to everyone, and currently has manufacturing locations in North America and Latin America. For more information please visit www.comar.com.