The pharmaceutical industry is one of the most regulated industries in the world. Pharmaceutical manufacturers are under immense pressure to protect consumers and patients from incorrectly manufactured drugs, medicines and medical devices, as well as protect themselves from the severe legal and financial penalties of supplying faulty products.
Investing in Eagle Product Inspection equipment can help manufacturers comply with Good Manufacturing Practice, in particular 21 CFR Parts 210 and 211, GAMP¬¬- 4 and 21 CFR Part 11, which are enforced by the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMEA) in Europe. For example, all our x-ray inspection systems are designed for easy cleaning and contact parts are constructed using FDA-approved materials.
Eagle x-ray machines provide exceptional detection of the following physical contaminants regardless of their size, shape or location within a variety of applications; from tablets, capsules and medical devices to powders and liquid medications:
- Glass shards (including glass within glass contamination)
- Metal fragments (including metal within foil and metalized film packaging)
- Mineral stone
- Some plastic and rubber compounds
- Calcified bone
In addition to ensuring products are safe, x-ray equipment is a quality assurance system. By allowing manufacturers to ‘see’ inside packages, x-ray inspection systems can protect consumers from poor-quality products by performing the following inline quality checks:
What’s more, metal packaging has no effect on the sensitivity of contamination detection and solutions are available to inspect products in the following packaging types:
- Tall rigid containers (including glass, metal and ceramic containers)
- Plastic containers
Manufacturers worldwide depend on Eagle x-ray inspection technology to check blister packs for many forms of anomalies, including broken or missing tablets. By looking deep inside final sealed packaging, our x-ray systems are simultaneously capable of counting needles, syringes or contact lenses in a box, checking the correct position of the locking lever in an asthmatic inhaler or the inclusion of instruction leaflets.
In addition, they also ensure liquid and powder sachets contain the correct dosage, and are widely used to ensure product safety and quality aren’t compromised by stray particles of product or foreign bodies trapped within airtight seals, to name only a few typical applications for x-ray equipment.