Packaging validation ensures that when your product reaches the customer it is:
- Preserved and protected
- Safe and fit to use and/or consume
- Identifiable and informative
- Sterile/microbe-protected.
What are the requirements for medical device packaging validation? The requirements for medical device packaging are very strict and must adhere to health and safety regulations across borders, highlighting the importance of compliance with packaging validation standards. At SteriPack the medical device packaging validation process is compliant with ISO 13485:2016 and MDD 93/42/EEC, Annex II.
What is packaging validation and why is it important? Packaging validation must address three basic elements: requirements, assumptions, and capability assessments (of materials, equipment, and processes); it examines variations within a package, from package to package, and from lot to lot.
When did validation become a requirement for sterile packaging? In May 1997, validation was raised as a GMP requirement with the issuance of Guidelines on General Principles of Process Validation. The new quality system regulation now specifically lists process validation requirements, and ISO 11607 provides key validation steps specific to sterile packaging.
What are the different types of packaging qualifications? Specific examples of packaging qualifications are: materials, initial design, equipment, process (performance), and product (performance) or final design (all of these qualification processes will be discussed later). The combination of the appropriate qualifications results in validation.
fda packaging validation
What are the steps of the packaging validation process? At this point, we’ve explained the first two steps of the packaging validation process. At PCL, we refer to the first step as the “ Make Pillar ” and the second step as the “ Ship Pillar ”. Next, we will explore the third step or the “Store Pillar”.
What is the FDA Process Validation Guidance? This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products.
Who are FDA packaging? Welcome to FDA Packaging Established in 1992 we have many years experience in Flow wrapping machines in the UK and worldwide, with many repeat customers. Our success, in large part, has been down to our key ethos, which our Machines are designed around; ‘flexibility, simplicity and durability’.
What is the difference between process validation and shipping validation? Just as process validation ensures the product is manufactured consistently to meet set parameters, shipping validation ensures the product or samples are delivered consistently to ensure product integrity.
What are the requirements for medical device packaging validation?
What are the requirements for medical device packaging? Appropriate packaging for medical devices should ensure product integrity and protect against damage throughout the entire supply chain. The requirements for medical device packaging are very strict and must adhere to health and safety regulations across borders, highlighting the importance of compliance with packaging validation standards.
Is the medical device packaging validation process compliant with ISO 13485? At SteriPack the medical device packaging validation process is compliant with ISO 13485:2016 and MDD 93/42/EEC, Annex II. EN-ISO 11607 Medical packing: ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
What is the standard for packaging validation of non-sterile medical devices? Literally there is no specific standard to follow for the packaging validation of non-sterile medical devices. However, the manufacturer must fulfil the requirement of GSPR. Thus, it is up to the manufacturer to select appropriate packaging for there medical device, and it should not be harmful to the function and efficiency of the device.
What does ISO 11607 mean for medical device packaging? ISO 11607 is the touchstone text for medical device packaging. This report will explore the validation requirements of packaging for terminally sterilized medical devices through ISO 11607.