Whitehouse Laboratories 661.1 and 661.2 Capable

With revisions to the current USP 661 looming, Whitehouse Laboratories is excited to announce that they are capable of servicing all customers under the proposed new regulations including 661.1 Plastic Materials of Construction and 661.2 Plastic Packaging Systems for Pharmaceutical Use. The United States Pharmacopeial Convention (USP) aims to improve global health in ways that ensure the quality and safety of consumer products. Recently, the agency published a draft recommending changes to their pharmacopeia that affect plastic packaging.

The proposed test chapter of the USP labeled 661.1 Plastic Materials of Construction provides testing rationale for plastic materials used in the manufacture of packaging components, such as resins. The convention states that the revision will determine key characteristics of a material such as:

  •     Identity
  •     Biocompatibility (biological reactivity)
  •     General physicochemical properties
  •     Additives
  •     Extractable metals

The revisions are aimed to ensure plastic packaging systems used by manufacturers will properly protect the pharmaceutical product, while being compatible with the drug formulation and safe for the end user. Pharmaceutical manufacturers must use packaging materials that ensure the product does not adsorb to, absorb into, or migrate through the package system. Furthermore, manufacturers must be confident that a packaging system does not emit any substances that may negatively impact product stability or the health of the end user. Plastics used in packaging are a mix of homologous polymers with a range of molecular weights and may contain residues such as:

  •     Plasticizers
  •     Stabilizers
  •     Antioxidants
  •     Pigments
  •     Lubricants

USP 661.2 Plastic Packaging Systems for Pharmaceutical Use provides test methods and standards for assessing package systems composed of materials considered well characterized through USP 661.1.

Ultimately, these changes to the USP represent a modernization of the chapter designed to create a well-characterized container closure system. Whitehouse Laboratories is uniquely qualified to perform the testing required to demonstrate full compliance with the proposed 661.1 and 661.2 chapters.

Whitehouse Laboratories maintains a “Container Testing Center of Excellence”, a facility dedicated to the multi-faceted assessment and development of containers and packaging materials. Their specifically trained staff members are on-hand to offer advice and provide more details about USP compliance capabilities.

About Whitehouse Laboratories
The Testing Partner to Manufacturing Companies, Whitehouse Labs is an FDA regulated, DEA-Licensed, ISO 17025 and ISTA certified contract service provider to the pharmaceutical, medical device, personal and consumer product industries. Whitehouse Laboratories offers analytical services for the testing of materials, finished products, container and package systems that enable our clients to meet and exceed the required quality standards established by the key regulatory agencies.