Achieving product excellence and regulatory compliance Wet wipe solutions for everyday professional care.

Achieving product excellence and regulatory compliance Achieving product excellence and regulatory compliance At Vernacare, we’ve been developing and manufacturing personal hygiene solutions for use in professional care for over 40 years. We’re passionate about offering healthcare professionals a range of cleansing solutions for assisted bathing and continence care which help provide tailored personal care, whilst supporting best practice in infection prevention. Lancashire, in the UK, is home to Vernacare’s specialist wipes facility. With 3 dedicated wipe production lines, producing over 20...

Achieving product excellence and regulatory compliance Achieving product excellence and regulatory compliance Regulatory landscape and classification routes The breadth of products supplied into the professional care and healthcare markets is varied and complex, and there isn’t a ‘one size fits all’ when it comes to regulatory classification of these goods. Many factors influence the regulatory pathway adopted by a manufacturer of healthcare consumables and/or devices prior to development and placement on the market – intended use or ‘purpose’ plays an important role in determining the correct...

Achieving product excellence and regulatory compliance Achieving product excellence and regulatory compliance The wet wipe classification debate Did you know? Classification of wet wipes as a cosmetic has been clarified a number of times in recent years… Despite their clear indication as a cosmetic product, the classification of wet wipe products used in healthcare settings has been debated over recent years, with some discussion around potential medical device status. In this section, we will review the justification for correct product classification. – During 2020, the Manual of the Working...

Achieving product excellence and regulatory compliance Achieving product excellence and regulatory compliance The product development process We take a collaborative approach to formulation and wet wipe product development. Led by a dedicated team of chemist and industry experts, we work alongside clinicians to develop products which meet the changing needs of healthcare professionals. Vernacare operate above and beyond the minimum requirements of Cosmetic Regulation (EC) No 1223/2009 when it comes to the rigorous testing methods used to ensuring product safety, customer acceptance and substantiation...

Achieving product excellence and regulatory compliance Achieving product excellence and regulatory compliance Quality control and procedures Investment in state-of-the-art customer-built machinery, and the adoption of quality standards help Vernacare deliver product excellence. Standards Our wet wipe cosmetic areas are certified against ISO 22716 Cosmetics – Good Manufacturing Practices (GMP) cosmetics. As a facility we operate under an ISO 13485 certification ensuring our quality management system is held to the standard used in the medical device field. Water quality A key component to the...

Vernacare Limited, 1 Western Avenue, Matrix Park Chorley, Lancashire, PR7 7NB, United Kingdom. T: +44 (0)1772 299900 F: +44 (0)1772 299901 E: [email protected] www.vernacare.com As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. Conti® is a registered trademark of Verna Group © 2023