How do you validate packaging?
It states that medical device packaging should be: Made of known and traceable materials. Non-toxic, non-leaching and odourless. Free of holes, cracks, tears, creases and localised thinning. Intended for use in medical applications.02-Dec-2014
Why is rigorous testing of packaging systems with medical devices mandatory?
In an effort to mitigate the potential risks to patients, regulators in the EU, the U.S. and other major healthcare markets have implemented strict requirements for packaging systems and packaging materials used to preserve the sterility of medical devices, protect their functionality and retain their biological safety 26-Sept-2018
Medical Device Testing and Scientific Support
What are the four pillars of packaging validation within the medical device industry?
Packing validation is performed to confirm that the resulting product from a specified packaging process consistently conforms to product attributes & requirements. Manufacturing and packaging facility has been qualified to meet cGMP requirements.28-May-2020
What is sterile packaging?
Sterile packaging is designed to keep bacteria and other microorganisms away from the contents of the package. It is used for food, utensils, medical supplies and any other material that can be compromised by germs.16-Aug-2022
Enteral Packaging Packaging of an enteral product in cans and glass bottles uses the same techniques and process as other consumer products in the same packages.
How many types of packaging are there in pharmaceuticals?
three types
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).31-Aug-2021
What are the top 3 challenges that underlie the medical device industry?
Let's look at the top 5 challenges faced by medical device manufacturers in the emerging markets:
Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.31-Aug-2018
What is the difference between PMA and 510 K?
A PMA is more in-depth than a 510k - it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.
The 510(k) clearance process doesn't require companies to provide safety or effectiveness data from clinical trials. But the FDA still evaluates the device's safety and effectiveness by comparing it to other devices. The FDA requires that companies submit a 510(k) at least 90 days before marketing the device.30-Sept-2021
Does 510 K need clinical trials?
The vast majority of medical devices on the U.S. market were given the government's green light in a process known as the 510(k), which requires no clinical trials and very little oversight.
Package integrity tests are used to detect packaging problems that could adversely affect the sterility of a medical device. Sterile products may be subjected to an environmental stress intended to simulate extreme conditions that a product might encounter in shipping or storage.
What is Process Validation in pharmaceutical industry?
What is Process Validation? The FDA defines process validation as, “…the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”.02-Aug-2022
Supplies wrapped in double-thickness muslin comprising four layers, or equivalent, remain sterile for at least 30 days. Any item that has been sterilized should not be used after the expiration date has been exceeded or if the sterilized package is wet, torn, or punctured.
How do you package sterile instruments?
Cloth wrapped packs sterilized and stored appropriately should have an expiration date of six months from the date of sterilization. 4. Peel packs sterilized and stored appropriately should have an expiration date of one year from the date of sterilization.19-Jan-2022
What are the different types of packaging?
Let's take a look at some of the different types of packaging options you can use to enhance your product & customer experience!
How do you validate packaging?