Article

Current Trends In Blister Integrity Testing And New Dimensions To Blister Economies
Courtesy: Parle Technology* Untold millions of medicinal tablets and capsules are produced every year, and many of the over-the-counter varieties are encased in blister packs for protection. Existing manual methods for inspecting these packages are subjective and lack repeatability, while electronic techniques have to date been stymied by the great variation in blister packages. In both of these cases, vision alone is not sufficient to meet the QC needs of pharmaceutical packaging, whether that vision is human or machine. To fill the gap, many technologies have been developed to produce a nondestructive test machine. Generalized statements often made, such as no detectable leaks or leak rate zero, no more represent an adequate basis for acceptance tests. Sealing must be quantified with an upper limit of an admissible leak rate. Experienced engineers know that properly formulated acceptance specifications will indicate a certain leak rate under defined conditions. Which leak rate is acceptable can be determined by the application itself. corresponding range of equipment. It is necessary to choose a leak detection method, which fulfills the defined needs of sensitivity and speed; the chosen method should not be more complicated and expensive than necessary. The public has never been so informed of package recalls as it is today. What have been acceptable quality standards are now more stringent. To protect the brand and maintain consumer confidence. Cost of insufficient package integrity testing Recalls Tracking and retrieving product, assessment Fines and legal fees Front page headlines Loss of customer loyalty Regulatory probation

Challenging Application
Blister packs are considered a particularly challenging application for leak testing due to the following characteristics: Flexibility of the package Multiple cavities in one package Small air volume inside each cavity Relatively high production output on automated packaging lines Flexibility of automated packaging lines resulting in frequent changeovers Various materials used Expensive product packed in a relatively inexpensive container Highly regulated industry.

Every corner cut in packaging quality control, opens the door for potential recalls due to poor seal integrity.

Inspection Methods
Assess specific needs to verify package quality Ensure package maintains integrity until product is used Determine how, when and why packages fail Evaluate inspection method and potential results Determine how results correlate to packaging process Quality control / process control

Package Integrity Common Misconceptions:

If you dont see a leak, it isnt leaking If you validate all packages and lines, you wont have leakage problems If you validate packages during R&D using dye or microbial ingress, no additional package integrity work will ever be needed

What is leak?
It is not easy to ascertain a wide-ranging definition for leaks. Nevertheless, a leak may be described as an unwanted path through an enclosure or a wall. Although most leaks may be found in both, vacuum and pressurized systems, some are typical for one kind of system. For example, leaks due to porosity are more typical to appear in the pressurized system owed to very highpressure difference, while virtual leaks are more common in vacuum systems. To find and measure leaks there are a wide range of methods available. These methods include a variety of technology from simple to highly sophisticated ones, with a *E-mail: nsreelkar@parleglobal.com

Why Recalls Occur

Lack of sufficient inspection Lack of process monitoring, process control Use of unreliable subjective techniques (manual, visual) Lack of proper process validation Poor component quality Inadequate maintenance

Ideal test method:

The ideal blister package leak testing systems do exist. The leak tester can, and should, meet the following criteria: Non-destructive and non-invasive No sample preparation Fast test time Conform to regulatory requirements Quantitative - Get hard data that means something High resolution, accuracy, repeatability Detects leaks regardless of packaging material:

The Bottom line

Package integrity testing has never been more critical than it is today.

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transparent or opaque plastic or elastic glossy or matte finish uniform or with print

5.

Non-contact: Laser-based sensors

fast and easy changeover practical for multiple-production line environments low maintenance user-friendly interface management friendly provides quantitative and qualitative data collection easy to validate; data integrity insured network ready

All blister package test methods that test for leaks do rely, to some degree, on measuring the physical expansion, contraction, or movement of the flexible lidding material during the test. If a test can accurately detect a defect based only on the physical aspect of the leak test, it will most likely detect all of the critical defects. The pressing question is, is the test truly practical for the needs of a blister packaging production line, and more importantly, is the test truly non-destructive? The brief description of each methods used for leak detection are given below 1. Methylene Blue dye testing The test sample to be leak tested is placed in a methylene blue dye bath. The bath is then pressurized such that if a leak is present in the test sample methylene blue will be forced to penetrate through the leak. The sample is then opened and inspected visually for any traces of methylene blue dye present inside the sample. The Blue Dye test is a huge waste of companys money. You have to throw away every tested pack whether or not it fails. The Blue Dye Test is only carried out every 15 minutes because it produces so many waste blisters. Therefore, if a leak is discovered it is entirely possible that every blister that was packed during the 15 minute period since the last test could also be faulty. The entire 15-minute production lot has then to be re-worked. Along with this other disadvantages of the traditional method of leak testing are as follows:

in vacuum correlate to presence of leaks and measures quality / integrity of entire package. The two methods used for the vacuum decay pressure method of testing of blister leak are:

Gauge Pressure Transducer:

Pressure decay is an older technology that has existed for many years. It is an indirect leak flow measurement with a leak rate based on decay rate and test pressure. Test volume is calculated for every set up. It is sometimes called calibration. Differential pressure decay offers a higher resolution and cost when compared to pressure decay. Pressure decay often gives an indirect measurement when calculating leaks. The changing test volume may give a bias reading. The operator must frequently calibrate during a part changeover or the operator can zero or mask a leak. Reference volume is required for this method, which is about twice the volume as pressure decay, which means twice the time to fill for each test. A differential pressure transducer is also required. Often, a large (gross) leak will cause an over-range of the differential transducer and damage or destroy it. Disadvantages: The sensor measures the test pressure or vacuum and is not adapted for measuring in a dependable and repeatable way tiny pressure drops. Those instruments are used to measure larger pressure drops. They can be equipped with solenoid valves (economy) or with custom designed pneumatic valves (industrial). Differential pressure transducer: The instrument compares a master non leaking part to a part under test. They are both filled at the same time. Here two sensors are used, one for the test pressure/ atmospheric pressure measurements, and one with a smaller range for the minute pressure drops. Disadvantages:

Reviewing Leak Detection Methodology

Package excitation: A package needs to be put under stress in order to inflict a possible detectable leak. Practically all known methods of blister package leak detection use vacuum (or vacuumpressure) cycles. The issues associated with it are: a. The stress should be low enough to consider the test method nondestructive. The excitation, on the other hand, should create enough difference of the pressure outside and inside the blister to drive measurable air flow throughout the leak hole. The transition from atmospheric pressure to vacuum takes time (evacuation time).

b.

c.

During this period some of the leak indicators are inaccurate. The little amount of air present in a blister cavity may be evacuated throughout relatively large leak before any measurement takes place. Test Chambers: Rigid test chambers are used in most test methods. Leak Indicators: Leak detection methods are mostly differentiated by indicators employed: 1. 2. Methylene blue dye test Vacuum decay measured by: Gauge pressure transducer Differential pressure transducer. 3. 4. Trace gas Contact methods: Displacement sensors Proximity sensors Contact load cell Observing the blue dye is cumbersome It works for validation purposes Extremely subjective Destructive Blue Dye Everywhere 2. Vacuum decay pressure: Vacuum decay method is not a locationspecific leak indicator. It can be used with a Single or dual transducer system. In this the test chamber connects to vacuum test system. Both absolute and differential vacuum are measured in the vacuum decay pressure method. Accordingly the changes

Want to have a heating solenoid, a moving valve seal, or just a small valve leak needs a sometimes bulky reference part. You need two sensors. The differential sensor that measures the minute pressure drops has to have a range of less than an inch of water but it has to resist to the test pressure. When measuring those minute leaks, you do not want to have a heating solenoid, a moving valve seal, or just a small valve leak: the valving is an expensive pneumatic

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3. Trace Gas:
A variety of tracer gases are available, the most ones common being carbon dioxide (CO2), hydrogen (H2) and helium (He). The measurement techniques differ greatly according to which gas is utilized. CO 2 is detected by infra red absorption, H2 by ion selective semiconductors and He by mass spectroscopy. The detection systems for He are somewhat more cumbersome and costly than those for H2. Hydrogen also has the advantage of simplicity of use and accessibility with minimal training. Disadvantages: Sensitive Slow test Complex test Potential for false readings Lab test

5. Non-contact Method: Laser Based Sensor:

the pocket and the vacuum outside. In the case of a good pocket the lidding foil will exhibit deflection that will be maintained throughout the period of constant vacuum.The working of laser scan method in case of good pocket pass is as shown below:

Fig.1: Non-destructive leak testing machine for blister packs utilizing the state-of-art non contact scanning technology at an affordable price. The perfect alternative for Blue Dye test

Leaking Pocket:Gross Hole> 30 Micron

In the case of a substantial leak path (pin hole size) the lidding foil will exhibit little or no deflection.The working of laser scan for this pin hole size is as shown below

4. Contact Methods:
The various contact methods used for leak detection in blisters is described below: Displacement sensor: Contact sensor methods could be destructive due to the amount of pressure put on the flexible lidding material of a blister package. Proximity sensor: Proximity sensors require difficult calibration and are not maintenance free. Changeover from one blister configuration to another is quite challenging. Variations of the product positioning inside the blister may produce false measurements. Proximity sensors also are only applicable to metallic lids. Fig.2: The drawer of the machine is opened and the blister pack is placed onto the plate depending on the dimensions of the packs. The drawer is closed to seal the test chamber. The operator presses the START button and the laser scanning technique starts.

Leaking Pocket Small Hole: 10 Micron-30 Micron:

In the case of micron order leak path the lidding foil will initially deflect but then relax after a given test period. In this case, the change in deflection is related to the hole size or the leak path through a weak seal area. Employing a secondary test phase can enhance this effect which is done by the laser sensor technique of blister leak testing device. Also, this allows the pocket head space to assume the same vacuum level as that of the test chamber. After this period the vacuum level in the test chamber is reduced. This causes the lidding foil to become concave, as the pocket headspace will be of a higher vacuum than that of the test chamber. The deflection and changes in deflection of the lidding foil are measured by a noncontact sensing system that scans the lidding surface of each blister pocket. The laser scan technique for a very minute pin hole size is as shown bewlow.

Load Cell:
Load cells can also be susceptible to the accuracy of a tablet placement and if there is enough air space between lid and top of the tablet. The initial force and geometry of the point of contact on the lid must be carefully evaluated based on the size of the blister pack and materials used. Particular model of load cell (in respect to the size and load range) could be used only on specific blister packs, which makes the test method very package specific. Force measured by load cell directly (but not linearly) reflects pressure inside the blister and, therefore, leak size. Nevertheless, difficult calibration is required in order to correlate force and leak size. The laser scans the surface of each pocket, measuring the height between it and the foil. A predetermined vacuum is applied to the test chamber. This causes the blister pocket to develop a deflection of the foil. A settling time takes place. This allows the system to stabilise. The evacuation scan is then made.

Fig. 3: Laserscan instantly pinpoints the location of a faulty pocket seal. Further graphical analysis is provided for each individual blister pocket. As shown the machine screen shows a pass(green) or fail(red) result for each blister pocket and also indicates the absence of a blister pack(black). Good pocket pass: A measurement in the deflection of the lidding foil of each blister pocket is taken both before and after a vacuum is applied to the test chamber. This deflection is caused by the difference between the pressure inside

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Thus, The laser based sensor mechanism can detect a leak in any format of blister pocket regardless of the shape of the pocket or whether the contents are tablets or capsules. It does not matter whether the lid is cold formed or thermo formed. The operator has no influence on the test results. Also during the test there is no contact with any contaminating substance. When detecting smaller leak sizes these methods do exhibit pressures that can be considered destructive. Non-contact laser methods are sensitive to print and reflectivity of the surface material of the blister pack.

Therefore the daily product cost of destructive testing (not including the labor cost, waste disposal and other miscellaneous cost) will be the cumulative multiplication of the above mentioned costs i.e. $ 640 Now the one time cost of buying a laser scan machine would be approximately $92,500 Hence the payback by using the Laserscan machine in operating days would be ($92,500/$640) i.e. approximately 145 days Along with this the continued annual savings by using a Laserscan machine over a methylene blue dye test would be the remaining 220 days of the year multiplied by the daily product cost of $640 ($640* 220) i.e. $ 140800 As can be seen from the above example,the traditional method of blue dye test is a huge waste of your companys money.You have to throw away every tested pack whether or not it fails.However, a

Laserscan method is not only a clean and dry test but is able to protect the blisterpacks from any damage during testing.You could save all the blisterpacks which dont have any leaks and put them back into the blisterpackaging line rather than throwing them away.

Conclusion:
With the increasing, stringent demands placed upon by the customers in the highly competitive and regulated pharmaceutical markets lot of care needs to be taken in the packaging of the product. One of the providers of the latest technology for leak detection of blister packing being SEPHA whose name is associated with quality machinery in the field of R&D blister packaging, product recovery and more recently for technological breakthroughs in non-destructive leak testing. To summarise, laser sensor detection of leak in blisters has much more advantages than the traditional and other techniques used which are listed as shown below:

Key Benefits Of The Laser Sensor Method Are:

Unlike the Blue Dye test, the laser scan test can be validated, so the results it produces are totally objective. This also means you don't need staff with special skills to carry out the test. The non-contact laser scanning method is clean and dry, unlike other destructive leak testing methods (eg Methylene Blue Dye Test), and does not destroy test product or packaging. Recovers costs of packaging and product by allowing the return of product to the packaging line. Saves downtime by locating the precise pocket which is leaking. An objective test with minimized operator error through pre-programmed test parameters. Reliable, validated process capable of detecting leaks as small as 5 microns Automatically stores audit trail data and test results. The use of a non-contact sensing device eliminates the possibility of foil damage. Self check of tooling before every test Affordable tooling

Which test methods offer the following features?

Blue Dye

Pressure Decay

Trace Gas

Contact methods: Load Cell

Non contact method: Laser sensor

Non-destructive to blisters and product No contact with product or blister pack Objectivity Detects leaks to 10 microns Convenient in use Identifies individual leaking pockets Self validation of sensor Tests whole web width No limit to number of pockets Self check of tooling before every test Print-out of results Clean and dry Can be used in production area Affordable tooling Bench mounting Can be easily validated Work station option For further enquiries and queries please feel free to contact parle global technologies at info@parleglobal.com

Other Features:
De-skilled easy to operate. Touch screen controls and graphic display of test results. Minimal time for product changeover. Fast test cycle. Example case study: To calculate how much money a company is losing with the blue dye test: A company X uses Methylene blue dye test for blister leak testing methods. The total number of hours of production per day for the company is 8 The total number of destructive tests performed per hour is - 4 The number of blister packs destroyed in each test is - 4 Number of tablets in each blister pack is -10 Value of each tablet is (end user price) - $ 0.5

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