Innovacyn, Inc. the family-owned company that makes Vetericyn Animal Wellness products, has always been in the business of providing animals with the best standard of care. Founder and chairman Bob Burlingame was Michigan raised on a farm with a deep respect for all animals, from horses and livestock to pets and wildlife.1 As he raised and bred horses later in life, he found many animal wound care products were old and dated technologies and knew there must be something better.
In 2009, Mr. Buringame launched Vetericyn products as his own solution to this common problem. He started the business in a small corner of a warehouse with only a few employees and producing only a few hundred bottles of animal wound care each month. Since then, Vetericyn has grown exponentially—the company’s team of over 50 employees now work in a 35,000+ square foot space, dedicating their time to manufacturing and sharing innovative animal health products with veterinarians and animal owners the world over.
All Vetericyn products are made in the USA with globally sourced components, and people in over 30 countries use and love the Vetericyn line.2 With animals all over the globe relying on Vetericyn, their team has invested in modern manufacturing facilities to provide safe, consistent, high-quality products.
Just a few years after launching Vetericyn, Mr. Burlingame then launched the human health brand Puracyn. Puracyn utilizes the same technology as Vetericyn and is used in hospitals and clinicsall over the world to treat chronic wounds.
Exploring Innovacyn’s Facilities
Walking through its state-of-the-art facilities, you can clearly see Innovacyn’s commitment to animal wellness. The 37,000 square-foot production and storage spaces include approximately 7,500 square feet of designated clean room space, creating a highly regulated, controlled manufacturing environment. With designated spaces for animal and human health, you can trust that each unit from Innovacyn’s factory is handled with attention and care.
To uphold consistent safety standards across the entire space, the manufacturing facilities are registered with the Food and Drug Administration (FDA), aligning with its rigorous Quality System Regulation standards.3 This means that Innovacyn carefully follows the FDA’s framework for planning and implementing manufacturing procedures—giving you and your customers reliable, consistent, and safe solutions for animal and human healthcare.
A Hygienic Manufacturing Environment
For any health and wellness product, cleanliness is a top priority. That’s especially true for Vetericyn—since its Vetericyn Plus products are designed to clean, treat, and aid healing, the production process starts with a hygienic environment. All production areas at Vetericyn qualify as Class 8 Cleanroom Environments. Cleanrooms are secluded within a manufacturing facility and have highly controlled environmental factors, such as humidity and lighting.4 Basic standards for Class 8 cleanrooms include:5
- Circulating air with a HEPA filter
- Limiting the density of large particles in the air
- Requiring protective garments for anyone entering the room
High Volume Production
As more veterinarians and pet owners use Vetericyn products, they put even more of a focus on bringing quality wellness products to scale. Currently, the manufacturing facilities can produce over ten million units each year (that’s over 800,000 units per month), allowing them to serve both local and international customers. From eye care to wound care to navel care, the Innovacyn manufacturing facility is comprised of versatile systems to support demand for all of its key product categories.
Rigorous Quality Standards
To continue its history of producing superior products, Innovacyn’s manufacturing space is compliant with key quality management standards from the International Organization for Standardization (ISO). ISO guidelines are the gold standard in quality management, combining the knowledge from subject matter experts to create standard criteria for safety, sustainability, and success.6 The specific standard Innovacyn uses to guide its manufacturing processes and equipment for Vetericyn and Puracyn is known as ISO 13485:2016.
ISO 13485:2016
ISO 13485 specifically outlines quality management systems for organizations that produce medical devices.7 Any product involved with treating diseases and medical issues can qualify as a medical device, making this standard a key guide for Vetericyn’s animal care solutions. It falls under the umbrella of ISO:9001 (an overarching standard of quality management), with added specifications for the medical device industry.
Innovacyn’s facilities operate in accordance with ISO 13485:2016, which is the most updated version and includes additional details on these key requirements:8
- Building infrastructure for quality-minded production methods
- Improving the design and development process
- Creating thorough regulatory documentation
- Handling consumer complaints
By using this ISO as a guideline for its own Quality System Manual, Vetericyn customers can place their full trust in the manufacturing processes, from design to delivery.
State-of-the-Art Machinery
Innovacyn’s setup is designed to seamlessly automate key aspects of the manufacturing process. Highly accurate pinch fillers inject a specific amount of product into each bottle, then labelers and case packers get each product ready for shipping. By incorporating state-of-the-art machinery into the manufacturing process, Innovacyn upholds its goal of flawless consistency. That’s what allows the company to stand by its 100% satisfaction guarantee – efficient, regulated processes from the factory to the consumer.
Quality & Efficiency
Equipped with ISO and FDA guidelines, Vetericyn designed a carefully curated production system that prioritizes the perfect balance of product quality and system efficiency. To monitor each item on the production line, the Vetericyn team has instituted thorough review processes. These include product tests that start even before the product is made and intermittent quality checks at every stage of production to ensure product safety and effectiveness.
During the pre-production phase, these quality checks include:
- Inspection of the raw materials used to produce the product
- Inspection of bottles and closures for defects
- Inspection of labels and boxes for content and legibility
- Routine maintenance and calibration of production equipment and machinery
During the production phase, the team continues to ensure product quality by:
- Monitoring product composition throughout bulk manufacturing
- Performing analytical testing on the bulk product prior to filling and packaging
Even during the filling process, Vetericyn goes above and beyond, inspecting:
- Fill weights
- Cap tightness
- Induction seal quality
- Lot and expiration dating
In the post-production phase, the Vetericyn team makes sure that each packaged product adheres to the brand’s high caliber of quality by:
- Performing a final round of analytical testing to verify the finished product’s composition
- Implementing two levels of quality review of batch production records for every lot
These standards are an essential step for creating trustworthy products for Vetericyn’s four-legged customers, just as they are for humans with Puracyn products. Infections and non-healing wounds are ubiquitous problems for humans and animals alike; Vetericyn, Puracyn, and the Innovacyn family are proud to provide innovative solutions with consistent quality and real-life results.
When operating at such a high volume, it’s critical to know where each unit is in the production lifecycle. That’s why Innovacyn stays organized with a state-of-the-art inventory tracking system that offers:
- Barcode management
- Tablet and phone scanning capabilities through the Anveo barcode system
- Instant updates, with up-to-the-minute data accuracy
- Microsoft Dynamics compatibility for direct tracking and robust reporting
Upcoming Expansion
Despite the impressive production capabilities of the current facilities, there’s an unprecedented demand for Vetericyn and Puracyn products. To ensure that every pet parent, farmer, veterinarian, or healthcare professional can access quality care, Innovacyn is expanding its facilities for its human and animal brands. One of the exciting new features for 2023 is a modern high-speed line that can produce up to 120 bottles per minute. By incorporating ultra-efficient machinery into current processes, Innovacyn will be able to reach new heights for its production, all right at home in the USA.
As facilities expand for Innovacyn, its commitment to providing quality wellness solutions remains the same. Caring for animals and humans involves caring about where their wellness products come from. With Vetericyn and Puracyn, you can put your trust in every step of the production process.
Sources:
- Innovacyn. Leadership. https://innovacyn.com/leadership/#1537723734736-0ad9ab4e-4bed
- Vetericyn. Vetericyn’s Story. https://vetericyn.com/vetericyns-story/
- Food and Drug Administration. Quality System (QS) Regulation/Medical Device Good Manufacturing Practices. https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
- Food and Drug Administration. Facilities & Equipment: CGMP Requirements (Cleanrooms – slide 29). https://www.fda.gov/media/92841/download
- American Cleanroom Systems. What Is An ISO-8 Cleanroom Classification? https://www.americancleanrooms.com/what-is-iso-8-cleanroom-classification/
- International Organization for Standardization. About Us. https://www.iso.org/about-us.html
- International Organization for Standardization. ISO 13485:2016. https://www.iso.org/standard/59752.html
- International Organization for Standardization. Quality Management for Medical Devices. https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100377.pdf
- International Organization for Standardization. Quality Management Principles. https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100080.pdf
