Sterile needle

safety

Spectra offers packaged sterilized needles and other medical devices in a series of TyvekTM 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. Standard or customized needles to fit customer specifications Customer contracted packaging solutions, specific testing and validation needs available Fast, easy customization of private labels EtO sterilization