Packaging Quality Control

Flex-Pack executes a well-established Quality System that has successfully passed audits by major Fortune 500 companies in the Agricultural Chemical, Pharmaceutical, Diagnostic Research, Industrial, and Military markets. Flex-Pack employs lot traceability at the finished goods level and conducts first article inspections. The Quality Inspectors conduct in-process testing followed by a final inspection at each step in the manufacturing process. Quality retains are collected and stored for a period of 12 months or for a timeframe specified by the customer.

Quality Inspection:

Below is the Quality Assurance Testing SOP that Flex-Pack performs on all orders. Flex-Pack'sTM Quality Department works with our customers to determine approved AQL levels for inspection based on lot size, run speed, and style of pouch. Our standard level for testing procedures is as follows:

100 to 500 Bags = 1/50
500 to 1,000 Bags = 1/100
1,000 to 5,000 Bags = 1/250
5,000 to 10,000 Bags = 1/500
10,000 or more Bags = 1/1,000

Pressure Decay Test ASTM 2095-01:

This is used to test seal/bag integrity under specific pressure using the MDT 500 leak tester. This instrument uses a basic Three-Step Process to check for leaks in bags.

Step One is the Charge Stage: First a fill pressure and test time must be determined. This is dependant on the bag size. The bag is filled to the determined pressure for a specific time. During the fill, the pressure is held constant.

Step Two is the Settle Stage: The air that is being pumped into the bag is shut off and the bag is left to settle under pressure for a specific time.

Step Three is the Test Stage: During this stage the leak tester measures the pressure decay during a specific time. A predetermined limit is set into the leak tester to determine a pass or failure. To put the pressure at the seals, restraining plates are used. The bag is placed between the plates. This reduces the volume of the bag. Unless there is a fitment on the bag or clamping jaws are used, this is a destructive test. Shown below are a depiction of the process of a pouch being charged, settling and the final test being evaluated/conducted:

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Pressure decay testing measures the change in pressure between atmospheric pressure and the pressurized test sample. This method yields quantitative information and hard data points that can be recorded and upon which decisions can be made. This removes any dependency on the operator and allows specific accept/reject criteria to be set. Shown below is a unit very similar to the one Pactech currently uses:

The tester will perform both seal strength and leak integrity testing. There are eight test modes for conducting both types of testing on the same nonporous package without having to change the setup, test item or instrument settings. Graphical results of individual tests and SQC analysis of readings in the data log optimize process control are shown below:

Instron Test ASTM F88:

This test is used to determine the strength of the material and seals on flexible materials. This instrument measures the force the seal or material can withstand before failure. In order to test a seal, a sample must be cut that is 1 inch wide and 3 inches long. The sample has the seal in the middle with two tails on either side. The two tails are placed into the clamps on the machine. The machine is turned on and the jaws start to separate. The amount of force, measured in lbs., is recorded. There are two needles on the dial one measures the force and the second is left at the maximum reading before failure. Shown below is one of our standard Tensile Strength Testers.

Bell Jar Test ASTM 3078-94:

The Bell Jar Test is used to determine gross leaks in flexible packaging. The pouch must be filled with air or other object and then sealed closed. The sealed pouch is submerged into a water chamber. After the lid is closed and the machine is turned on, a vacuum will begin to form. The internal vacuum pressure of the tank is measured in inches of mercury and can be read on the pressure gauge. The Bell jar has a range of 0-25 inches of mercury. Any leaks will show by producing air bubbles. Shown below is one of our Bell Jar Testers that is used to accept/reject pouches.

Continuous Improvement:

Continuous improvement initiatives are driven through Flex-Pack's PPI Program. The Practical Process Improvement program is a proven hands-on methodology where teams of employees learn the tools and immediately apply them to a real business problem in their functional area. Measurable results are key to process improvement. The teams collect data, analyze it to find a solution, and then test the results, using metrics. Once the solution has been proven effective, the team implements and then monitors the solution to ensure that the results are sustained. Continuously improving our processes enables us to increase our productivity and to expeditiously deliver quality products and services to our customers at competitive prices.