SHL Group, a privately owned developer of drug delivery systems, has established SHL Pharma to provide final assembly, labelling and packaging services of drug delivery devices such as autoinjectors for the pharmaceutical and biotechnology industries.
The addition of SHL Pharma, which includes a 45,000ft2 facility in South Florida, US with 30,000ft2 of manufacturing space and customised cleanrooms, will enable SHL to take projects from design to distribution. To ensure the automation equipment in-house can accommodate specific assembly needs, SHL Automation has built many of the machines.
The SHL Pharma plant follows Leadership in Energy and Environmental Design (LEED) guidelines and aims to minimise environmental impact by optimising energy performance; using alternative transportation; reducing water usage; managing waste; and using renewable materials.
With construction and renovations completed in April, SHL Pharma is in the process of obtaining ISO 13485 certification, and will be registering with the US FDA as a Drug Establishment, qualified to handle and distribute pharmaceutical products. Additionally, it will conform to all other regulatory requirements for medical device and pharmaceutical packaging and distribution, as per 21 CFR Parts 820, 210 and 211.