Key Points
- Bottles are used in the pharmaceutical industry for a wide range of products, like liquids, tablets, and capsules.
- Bottle filling machines not only fill your bottles, but they also count your tablets or capsules accurately and efficiently.
- To meet good manufacturing practices (GMP), glass and plastic bottles must pass a leak test.
- There are a variety of non-destructive leak testing (NDT) methods used to detect packaging leaks.
- Bottle leak detection equipment is crucial to ensure seal integrity before shipment.
Different Types of Pharmaceutical Bottles
Bottles are used in the pharmaceutical industry for a wide range of products, like liquids, tablets, and capsules. Manufactured with either glass or plastic, the bottle type depends on the product inside. For example, glass bottles are ideal for sensitive products and liquids stored for long periods. However, plastic bottles are more versatile and a great option for various nutraceuticals and pharmaceuticals, like vitamin D and ibuprofen.
Whether you choose a plastic or glass bottle, it’s essential that your packaging protects the product inside from damage and degradation.
The Pharmaceutical Bottle Filling Process
The pharmaceutical bottle filling process includes several intuitive, sophisticated sensors that work together to accurately fill and count tablets and capsules. Designed with air cylinders that prevent spillage and process changes before filling takes place, bottle filling machines not only fill your bottles, but they also count your tablets or capsules accurately and efficiently.
Explaining Non-Destructive Leak Testing
Even after the bottle filling process, your product isn’t ready for shipment quite yet. To meet good manufacturing practices (GMP), glass and plastic bottles must pass a leak test. If your packaging fails, your product becomes exposed to oxygen or moisture, decreasing its quality and shelf life.
There are a variety of non-destructive leak testing methods used to detect packaging leaks:
Vacuum Decay Leak Test
Used to ensure container closure integrity (CCI), the vacuum decay method identifies packaging defects and micron leaks for the pharmaceutical, medical device, and food packaging industries.
Pressure Decay Leak Test
Pressure decay leak testing is often used to test vials and ampoules that contain toxic products, oil-based liquid or lyo powder, glucose protein, or other products that can’t be tested using the vacuum decay method.
Vacuum Deflection Leak Test
A common NDT method for blister packs and packaging with multiple cavities, the vacuum deflection leak test uses a 3D volumetric scanner to measure package deflection surfaces as they respond to an applied vacuum. Depending on the pack and material type, the 3D scanning technology can provide results as low as 5 microns.
The Importance of Bottle Leak Detection Equipment
Bottle leak detection equipment is crucial to ensure seal integrity before shipment. Weak or partial seals can occur during the final sealing stage, so it’s important to use a non-destructive leak testing method to minimize recalls and reduce costs.
The Sepha BottleScan: An Innovative Bottle Leak Testing Machine
Ascend Packaging Systems recommends the Sepha BottleScan for an accurate leak test procedure for bottles. A non-destructive, deterministic, and tool-less bottle leak testing machine, the Sepha BottleScan uses a multi-bottle leak tester for induction-sealed pharmaceutical bottles containing dry products.
The BottleScan can detect leaks down to 15 microns, testing up to four bottles per cycle in 30 to 90 seconds depending on the bottle type. Its tool-less design ensures a quick changeover between bottle sizes, making this innovative bottle leak testing machine an ideal solution for production lines with multiple products. The BottleScan can store up to 30,000 recipes, is GMP certified, and can be part of a system that’s 21 CFR Part 11 compliant.
Force Decay: An Efficient Leak Test Procedure for Bottles
The BottleScan uses the force decay leak detection method to ensure seal integrity. Force decay works by placing an induction-sealed bottle into a nest that includes a strain gauge load cell housed within a vacuum chamber.
The vacuum is then applied to the chamber. The flexible induction seal expands under the chamber, generating an expansive force in response to the vacuum. Next, the strain gauge load cell measures the expansive force to determine if the bottle or induction seal has a gross, micron, or no leak:
- If there’s a gross leak, no expansive force is measured.
- If there’s a micron leak, expansive force is measured, but as the bottle or induction seal lets air escape into the vacuum chamber, the force decreases.
- If the bottle or induction seal passes the test and has no leaks, it expands under the vacuum, remaining inflated and generating a constant force measurement over time.
Offering High-Quality Bottle Leak Testing Machines
Testing machines like the Sepha BottleScan are a high-speed solution for precise and efficient leak testing. We offer high-quality bottle leak testing machines, including the Sepha BottleScan, PakScan, and MediScan. Whether you work in pharmaceuticals, animal health, or even cannabis packaging, industry standards must be met for every bottle or package. No one in the packaging industry understands the importance of compliance more than Ascend. Contact us today to learn more about our bottle leak testing machines.
