|Company/Department |Authorized Signature |Date |
|Integra Biotechnical, LLC, Engineering | | |
|Integra Biotechnical, LLC, Manufacturing| | |
|Integra Biotechnical, LLC, Quality Assurance | | |
|Merit Medical Systems | ||
2 The objective of this protocol is to establish and validate the process operating window used to produce Merit Medical Systems MDD 600 Clear Bag will meet or exceed all the defined specifications.
3 This Operation Qualification protocol will perform a process optimization study based on a (DOE) “Design of Experiment concept. This study will be used tooptimize the Radio Frequency sealing parameters.
5 This protocol applies to the MDD 600 Clear Bag, which is a component, sold to Merit Medical Systems and will be manufactured at Integra.
6 This protocol includes the DOE and Operational Qualification activities.
7 This protocol includes dry leak test parameters qualification activities.
8 Design ofExperiment (DOE): A methodology of varying many input factors simultaneously in a carefully planned manner, such that their individual and combined effects on the output can be identified.
9 Interaction: The effects of one factor on the output of another factor
10 Full Factorial: Describes experimental designs which contain all combinations of all levels and all factors.
11 Optimization:Involves finding the treatment that gives the most desired response.
12 Factor: Process parameter.
13 Treatment: A single level assigned to a single factor during an experiment run.
14 Treatment Combination: A set of levels for all factors in a given experimental run.
1. Response Surface: Graphical representation of the connection between important independent variables, controlledfactors and dependent variable.
2. Lower level designation (-), Upper level designation (+)
2. Operational Description
15 The bag will be made using parameters determined during the DOE and validated using a radio frequency (RF) welder. This RF welder will be used to seal the periphery and tube port areas of the bag utilizing a two stage welding process. The welder will have afixed die set with two stations.
16 Production Summary
17 PVC Material will be sheeted and manually placed onto the base plate. Then the PVC tube ports will manually be loaded onto the mandrels. Another sheeted PVC sheet will be placed over the first PVC sheet and tube ports. The press is then cycled. The bag will manually be removed, stripped of the waste material, hotstamped; components will be assembled using cyclohexanone and 100% leak tested.
18 The RF machine applies a force between the two plates (Psig) this force is applies by the RF press machine to the film material, the Energy RF is controlled by a Pre-Seal time, First Weld time, First Cool time and Mandrill Power these settings controls the energy that flow to the Port. The Delay, Second Weld time,Second Cool time and the Flat Power these setting controls the energy that flow to the plate. Some machines use a preheat plates in order to reduce the RF energy and maximize the seal.
19 DOE Sampling
20 Treatment combination indicated in table 1, two (2) cycles per cavity (die has two cavities) will be run. A total of four (4) units will be evaluated for each treatment combination.