Before being placed in the market, all drugs are required to pass multiple quality tests to guarantee safety and to certify the integrity of their packaging. This ensures the products can safely maintain their shelf life and still be viable when administered to the patient.
Although testing is very important for every type of pharmaceutical product, some categories, such as injectable products and drugs, require special attention because of their specific characteristics. Visual Inspection methods ensure that international standards are met with the necessary accuracy and precision.
Injectable Products and Drugs: Special Characteristics
Injectable (or parenteral) medicines are administered intravenously, intramuscularly or subcutaneously. This means that they do not pass through the gastrointestinal tract but enter the circulation immediately.
This method of drug administration effectively meets various needs:
- The injected drug is assimilated very quickly and with a high margin of safety, making this route of administration particularly useful in urgent or emergency situations.
- Products that are not assimilated optimally when given orally (including life-saving drugs, such as heparin or insulin) can be administered to patients effectively via the parenteral route.
- Because of this packaging type —such as pre-filled syringes for vaccines or auto-injectors for insulin—parenteral administration ensures that patients receive medication quickly, effectively and safely, even in situations when perfect hygiene cannot be guaranteed.
Although injectable drugs meet many healthcare requirements, they also require special attention when the integrity of their packaging is being inspected. These products are absorbed by the body quickly, and are entirely bioavailable.
Because of this, international regulation requires that packaging integrity be tested for all injectable products. Every single bottle or injection device must be inspected individually before it can be shipped, as contamination or product dispersion could have extremely serious consequences for patient health.
Visual Inspection of Injectable Drugs
Visual Inspection, both in its traditional version and in combination with neural networks (AVI – Automatic Visual Inspection) is an internationally approved test method for injectable products.
A visual inspection machine identifies defects in both the packaging and the content of bottles or injection devices, detecting the presence of elements that can indicate that the product does not comply with expected quality standards.
Visual Inspection can detect:
- scratches, cracks or inclusions in the container containing the drug
- foreign bodies inside the container
- particulate matter inside the bottle
- a broken or incorrectly positioned cap
- an incorrectly positioned plunger in a pre-filled syringe
- errors in the fill level of the container
- abnormal color of the product
All of these defects indicate that the drug or its packaging has not been manufactured, handled or stored correctly, therefore, it is not suitable for use .
Visual Inspection Applied to Parenteral Products
As previously stated, 100% of parenteral products must be tested and pass inspection before they can be distributed. This means that the only testing methods suitable for package inspection are non-destructive ones. These methods include deterministic analysis (such as Headspace Gas Analysis, the Vacuum Decay Method and the Pressure Decay Method) and probabilistic methods, such as Visual Inspection.
The most recent revision of USP <1207> suggests that deterministic methods should be used whenever possible. Due to innovations in the field of visual inspection, this method can be used with a high degree of safety to inspect parenteral products.
The application of neural networks to the Visual Inspection technique significantly increases its ability to provide accurate and reliable results, minimizes the number of false rejects, and accurately identifies all products having anomalies that would render them non-compliant to safety standards.
As we have previously covered, Visual Inspection can also identify a wide variety of defects in a single test, ranging from product color variations to the presence of scratches in the container.
Because of its capabilities, Visual Inspection is an optimal method for inspecting the packaging integrity in injectable products and drugs, guaranteeing high levels of accuracy, reliability and safety.
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