Prince Sterilization Services
Spearheading Sustainability in Sterilization

Prince Sterilization Services [Prince] is at the forefront of transforming outsourced sterilization into a model of sustainability. Since its inception in 1970 as the family-run Gibraltar Laboratories, it has evolved into a leader in medical device and pharmaceutical sterilization. Now spanning three generations of Ph.D.-level ownership, Prince combines over half a century of innovation and expertise with a commitment to advanced, environmentally-conscious sterilization methods.

“As the healthcare industry increasingly embraces greener practices, we continue to lead the way, blending decades of expertise with a commitment to quality, innovation, and environmental stewardship,” says Derek Prince, Ph.D., President.

Prince is dedicated to implementing eco-friendly and operatorsafe sterilization practices for pharmaceuticals and medical devices, upholding rigorous quality and safety standards while contributing to a more sustainable future. It employs advanced sterilization methods, such as steam, dry heat, and low-temperature vaporized hydrogen peroxide, that ensure sterile medical devices meet the highest standards. The solutions are offered for a diverse range of devices, including pre-filled syringes, orthopedic implants, heat- and radiationsensitive devices, and implants with electronics and sensors. Operating over 50,000-square-feet of state-of-the art cGMP space, Prince adheres to stringent FDA regulations and ISO 13485 standards, ensuring full compliance and reliability. Its commercial-size chambers are designed to handle a wide array of sterilization needs, including those of medical device manufacturers looking to outsource their sterilization and packaging requirements. Prince’s eco-friendly, sustainable methods are designed to be safe for customer products, neighboring communities, and operators.

Leading the Way in Eco-Friendly, Advanced Sterilization Solutions

Prince embraces eco-friendly practices throughout its operations, particularly through the use of vaporized hydrogen peroxide (VH2O2) for sterilization. This method significantly reduces environmental impact compared to traditional ethylene oxide (EtO).
“We believe that innovation and sustainability go hand in hand. As we advance technology, we also strive to protect our planet for future generations,” says Prince.

With increasing regulatory pressures to curb EtO use due to its risks, Prince has emerged as a leader by offering VH2O2 as a safer, more sustainable alternative. The FDA’s recent classification of VH2O2 as a Category A sterilization method, supported by the new ISO 22441:2022 standard, highlights Prince’s pivotal role in this industry shift. Prince remains dedicated to advancing sustainable sterilization practices, solidifying its position as a key advocate for eco-friendly solutions.

Prince is also at the forefront of innovative research, exploring the compatibility of low-temperature vaporized hydrogen peroxide sterilization with pre-filled syringes. The focus of this research is to ensure that the process is effective as well as safe, avoiding unwanted movement of stoppers within syringes and eliminating the risk of contamination. It is also investigating how quickly vaporized hydrogen peroxide degrades compared to other sterilization methods.

Tailored Solutions for Specialized Sterilization Needs

Prince offers its eco-friendly and advanced sterilization solutions to companies of all sizes, ensuring that every medical device manufacturer can benefit from its specialized services. In an industry where larger companies tend to focus on high-volume clients, Prince prioritizes tailored, high-quality services for lower to middle-volume production, ensuring that every company, regardless of size, receives the same excellence and attention to detail.

Working closely with manufacturers from the outset ensures that medical devices and packaging are designed for optimal sterilization. Prince supports clients throughout the product lifecycle, from initial development and validation to commercial production, ensuring that each device meets stringent regulatory and safety standards. Prince conducts all sterilization procedures within cGMP manufacturing space. Advanced equipment, including state-of-the art vaporized hydrogen peroxide sterilizers and dry heat and steam sterilizers built from 316 stainless steel and fed with water for injection, ensure superior performance and reliability. Prince is registered with the FDA as a contract sterilizer for pharmaceuticals and medical devices.

Beyond sterilization, Prince excels in providing sterile Ready-to- Use (RTU) components, including essential drug product components like glass vials, stoppers, seals, and closures. These products are crucial for contract manufacturing organizations, pharmaceutical companies, and compound pharmacies. Prince’s capabilities extend to clean room packaging and kitting, ensuring that medical devices and pharmaceutical products are securely contained and protected throughout their lifecycles.

Prince’s commitment to quality is reflected in its impressive regulatory record and consistent customer satisfaction. A state of readiness is maintained for audits and inspections, regularly exceeding the expectations of customers and regulatory bodies. That commitment is complemented by agility, the swift resolution of customer needs and issues, and close collaborations to devise effective solutions.

In its more than 50-year journey in the sterilization industry, Prince Sterilization Services has consistently exemplified innovation and dedication, earning its reputation as the industry’s trusted choice for advanced, eco-friendly sterilization solutions.