Packaging integrity tester in pharmaceuticals the ability of a pharma packaging to contain, sustain and protect the product inside. It simulates different factors that could cause damage to the packaging. It checks to see whether the packaging can withstand these damaging factors. It checks the condition of the packaging and also observes the product inside it.
If packaging and product have no effect, the packaging is said to pass the integrity test. On the other hand, if the product and packaging are affected by these external factors, the integrity test has failed. The packaging process is evaluated for shortcomings or problems until it passes the test.
Importance in Pharma Industry
Packaging integrity testing is critical in ensuring product safety throughout its life cycle until it reaches the end user. It ensures the efficiency of pharma packaging to deliver the pharma product in its original form against external factors such as extreme temperature, storage conditions, and logistics.
Some ways the packaging integrity testing helps the pharma industry include the following:
Detect Defects in Pharma Packaging
There are two most common sources of defects in packaging – holes, and leaks. When they exist, they can affect the packaging and damage the product inside.
Leaks and holes in pharma packaging are often invisible to the human eye. Even experienced pharma professionals can go without detecting these leaks and holes. Additionally, some packaging looks satisfactory during the routine physical examination but may contain minute holes or leaks. These problems become more intense as the packaging becomes exposed to extreme environmental or weather conditions.
Packaging Integrity testers can detect small and minute holes that aren’t visible to the human eye. The test can indicate individual packaging containing the hole. Some tests can also indicate the intensity of the hole by performing quantitative analysis.
Similarly, an integrity tester can indicate any loose or in-efficient sealing during the packaging process.
Packaging integrity testing is also required as a part of regulatory requirements. Pharma product manufacturers must arrange for reliable packaging integrity testing equipment for accurate and reliable integrity testing of packaging material.
During their routine inspection, regulatory bodies review the results of packaging integrity testing as part of batch history records or preparation documentation. If a regulatory body finds any discrepancy during its inspection, it can issue a warning or even shut down the operation of that pharma product.
Helps in Optimizing the Packaging Process
The results of packaging integrity testing can be used to optimize the packaging process in the pharmaceutical industry.
Because sometimes, packaging equipment seems to be running satisfactorily, and there seem to be no visible defects in the overall appearance of the packaged product.
Packaging equipment often has a mechanism to monitor machine parameters such as machine speed, temperature, and pressure. However, the accuracy of these machine parameters can only be verified by third-party tools, and packaging integrity testers offer a great tool for monitoring the accuracy of machine parameters.
Packaging integrity testers provide insight into the packaging process, and it enables personnel to set operating parameters that best match the requirements of packaging integrity testers.
Packaging integrity testing builds confidence in the packaging process of a pharma manufacturer and ensures safe production and reliable product. This, in turn, results in increased customer satisfaction, market share, and less recall and complaints.
What other industries can integrity testers serve?
Packaging integrity testers are used in pharmaceuticals and in every industry where the product comes in direct contact with humans. Out of many, the two most common use packaging integrity testers are medical devices and Food & Beverages. Let’s briefly overview Packaging Integrity Testing in these two industries.
Packaging integrity testing is used to detect any leaks or holes in a packaged medical device. Leaks can be a source of harmful contaminants or foreign bodies in the packaging and can come into direct contact with the medical device. A leak can occur due to uneven or weak sealing between packaging materials. Weak sealing can also cause a hole in the packaged device, which can penetrate foreign bodies inside.
Packaging Integrity Testing helps to point out these holes and leaks. These tests only identify leaking points or a hole in the packaged device and do not measure the size and quantities of leaks or holes.
Microbial Immersion Tests, Dye Penetration, Vacuum delay, and High voltage leak detection types of integrity testing are commonly used for medical devices.
Food & Beverages
Like pharmaceutical industries, food & beverage also come in direct contact with human consumption. For the safety and reliability of these products, their package is tested with package integrity testing.
Packaging integrity testing is used to test the container in which food item is packaged. It tests the packaging material’s effectiveness in protecting the food items from harmful foreign bodies.
Example of packaged items on which Integrity is performed includes Cans, Drinks, Baby foods, ready meals and trays, pet food, and dairy items.
For Food & Beverages, vacuum decay and Lid deflection methods are used
The vacuum Decay method uses a vacuum to detect leaks in the container. Other methods use sensors to check the positioning of the protective lid or cover. This method can detect leaks or holes without opening the container or touching the food items inside.
Working Principle of Packaging Integrity Testing
The working principle of packaging integrity testing depends on the particular type of integrity tester. Every type, such as Vacuum Decay and Microbial Immersion, has a different procedure for checking the Integrity of packaging.
Generally speaking, the following is the working principle of packaging integrity testing.
The sample product is exposed to external factors, against which the packaging requires testing. Depending upon the product being tested and the protection required, there can be different factors.
The packaging is exposed for a specified time.
After time has elapsed, testing is stopped.
After testing, the sample is physically checked for any deformation or change in its physical characteristics. In some tests, the product is also tested for microbiological testing.
The packaging is also tested for any leaks or breaches.
If the product or the packaging remains unchanged in its characteristics, the test is passed, and the packaging process continues.
If the test fails, the packaging process is analyzed for any discrepancy.
What types of packaging can be tested.
In the pharmaceutical industry, every packaging that contains a product is tested for Integrity using different testers. Some common packaging tested in the pharmaceutical industry includes the following.
Blister packs are used for packing bottles and tablet forms of oral dosage. A blister pack comprises two different packaging materials, and a product is placed between them. During the blistering process, the chances are that packaging materials are not tightly sealed, reducing the ability of blister packs to protect the product. There are also chances that there might be holes in the packaging material.
Blister packs are subject to an integrity test called Leak Test. In this test, a blister pack is placed inside a vacuum chamber containing a colored solvent.
When the vacuum is applied, any leak in the sealing or hole will cause the solvent to penetrate inside the blister pack. The traces of liquid can be identified by physically examining the product inside the packaging.
Pouch packs are formed by sealing packaging paper around a pharma product. Typically it is used as secondary packaging for ampoules.
Integrity testing for pouches is used to check the Integrity of a pouch. The common method uses vacuum decay, in which a pouch pack is used to subject to vacuum in a container. A colored solvent is introduced in the container. Under vacuum conditions, the liquid solvent is pressed against the pouch. The solvent penetrates into the pouch if there is a leakage or a hole in the pouch pack. The traces of solvent can be checked by physically examining the product inside the pouch pack.
Ampoules and Vials
Ampoules and Vials are used to pack liquid in injectable form.
After filling the product, the ampoules are sealed, while the vials are capped and sealed.
There are chances that there can be a leakage or hole during the capping and sealing process, which can become a source of penetration of foreign bodies or contamination.
Integrity testers are used to check the Integrity of ampoules and vials, especially if any leaks and holes occur during the sealing process.
Bottles are used to fill the liquid form of pharma products. After filling, bottles are sealed and capped. Like other packaging types, chances are that there can be leaks in the seal, and it can be due to
Poor quality of cap material. in this case, if the seal is tight, even then, it can cause a leak and result in penetration of foreign body objects
Poor capping process: it can be due to a problem with the capping machine. In this case, high class and perfect material will not affect the Integrity of a product inside the bottle.
Integrity tests are used to detect a problem with the bottle that could result in leaks and holes. It helps to provide optimum parameters that result in authentic bottle packaging without damaging the product, increasing cost and wastage.