Spectra offers packaged sterilized needles and other medical devices in a series of Tyvek™ chevron peel
pouches with a standard single color 2” x 4” label in a white chipboard or fluted shelf box. A strong
experienced Quality Control Department, and validated packaging and sterilization processes, support this
offer. The packaging facility with a class 100,000 cleanroom, and the state-of-the-art sterilization facility,
have ISO 13485 certification.
Spectra will provide appropriate studies establishing SAL, Bioburden, Non-Pyrogenicity, Nontoxicity,
package integrity and EtO residuals, as well as bacteriostasis and fungistasis for the standard products.
Spectra will also work with customers for custom needle requirements to address testing and validation
needs for their specific product requirements.
Spectra’s new dedicated packaging facility with fully validated packaging processes is available for our current contract packaged sterile needles, and for customers looking for contracted packaging solutions to market their products as quickly and easily as possible; with an array of packaging options to meet the customer’s needs; private labeled of products, and EtO sterilization.