Pharmaceutical manufacturers face many challenges, from safeguarding brand reputation and protecting consumers' welfare to complying with legislative and regulatory standards. To ensure the quality and safety of all Pharmaceutical and Medical Device products, each product should be inspected to make sure they meet the safety and quality standards.
METTLER TOLEDO Safeline's X-ray inspection systems have the ability to perform a wide range of in-line product integrity checks in a single pass, including identifying missing or broken items in blister packs and fill level monitoring in bottles.
X-ray inspection can also inspect a wide variety of medical devices by counting needles and syringes in a box, checking the correct position of the locking lever in an asthmatic inhaler, counting the amount of contact lenses or checking transfusion bags for contaminants and integrity. In addition x-ray inspection is capable of detecting physical contaminants such as metals, glass and high density plastics in pharmaceutical products.
Whether pharmaceutical manufacturers produce tablets, capsules, powders, liquids or medical devices: Safeline X-ray supplies tailored solutions to meet any specific need or requirement for the production line.
Effect of X-rays on Pharmaceutical Products
During inspection of pharmaceutical products, the quantity of x-rays is low, the energies of the individual x-rays are relatively low and the inspection period is very brief. Tablets under x-ray inspection are typically exposed to low energy x-rays for less than 0.2 seconds. The dose levels of background radiation received by pharmaceutical products while on the shelf, in transit, or during the time they are owned by the consumer are much higher than the levels delivered by an x-ray inspection system on a production line.
The US Food and Drugs Administration (FDA) estimates the dose level received by an object going through an x-ray inspection system is lower than the background radiation dose level for one day. Moreover, the FDA asserts that there is no known danger to consuming medicines that have been inspected by x-ray.
Regulatory compliance is key for manufacturers in the pharmaceutical industry. Mettler Toledo's EQPAC is an optional offering for the pharmaceutical industry that includes IQ/OQ/PQ procedures for FAT and validation. These documents can be customized to our customer's specific configurations to ensure a complete a thorough validation process.
Safeline X-ray software assists our customers with maintaining 21 CFR Part 11, which is a FDA regulation related to the use of electronic records and electronic signature. X-ray inspection systems support pharmaceutical manufactures in complying with this regulation thanks to their ability to log all activities that take place on the system, including storage of rejected images for traceability and audit requirements. Individual log in credentials are also required for operators, supervisors and maintenance. Each user's access levels can be customized by the administrator in accordance with the user's usage rights.
Based on individual pharmaceutical manufacturer's requirements, METTLER TOLEDO Safeline X-ray ensures its product inspection systems achieve reliable results right from the start. We offer a broad range of training courses and provide a selection of services to maximize the investment through the life span of the system.