Turn-key sterile & non-sterile medical packaging solutions, cleanroom pouching, heat sealing, and VideoJet labeling tailored for global medical device manufacturers.
C.G. Laboratories, Inc. delivers ISO 13485:2016 and MDSAP-certified medical device contract packaging services engineered for international medical device brands and OEM healthcare manufacturers. Operating within FDA-registered facilities and ISO 14644 Class 9 cleanrooms, we ensure optimal barrier protection, sterility assurance, and strict compliance with FDA QSR and international quality standards.
Every packaging project adheres to a validated, audited, and continuous control process to protect product integrity from material intake to global destination shipping.
We perform comprehensive technical evaluations of your device geometries, material compatibility, target market regulations, and shelf-life requirements to construct a tailored packaging specification.
Selection of medical-grade substrates including Tyvek®, foil laminates, breathable membranes, and thermoformed rigid trays to guarantee sterile barrier integrity during transit and storage.
Executed inside our ISO Class 9 cleanrooms using validated heat sealing, vacuum sealing, and ultrasonic sealing systems monitored for precise pressure, dwell time, and temperature controls.
Coordination of sterilization processing (EtO, Gamma, E-Beam) alongside seal integrity testing (ASTM F88 / ASTM F1929) and accelerated aging studies to prove packaging durability.
Integration of high-speed VideoJet printing systems for sharp, compliant Unique Device Identification (UDI) barcodes, batch/lot tracking, manufacturing dates, and custom branding.
Final visual, peel strength, and seal integrity inspections followed by secure staging in climate-controlled warehousing ready for global freight distribution.
Bringing over 40 years of scientific leadership, our integrated laboratory, sterilization, and contract packaging operations streamline your vendor management and lower compliance risks.
Controlled environments with routine environmental monitoring (airborne particle counts, bioburden surface sampling) to prevent particulate and microbial contamination.
From hydrogel formulation, device decontamination, packaging integrity testing, to bioburden and sterility release testing — all under one centralized QMS.
Capacity built for agile low-volume R&D pilot runs as well as scalable high-volume commercial production for multinational hospital distribution networks.
Comprehensive Certificate of Analysis (CoA), validation protocol execution reports, and compliance documentation supporting FDA 510(k) and EU MDR filings.
We collaborate with global supply chain managers, quality managers, and medical device engineers across diverse medical sectors:
Key information for overseas purchasers, quality auditors, and medical device importers evaluating C.G. Laboratories.
