Blister machine with OEB5 containment system

For the packaging of oncological products, the blister machine mod. TF120 designed and manufactured by Famar Tec, in collaboration with FPS, guarantees a maximum level of protection (OEB5).

 

Pharmaceutical production has changed significantly over the last 20 years and products containing the so-called "Higly Potent Active Pharmaceutical Ingredients" (HPAPI) play an increasingly central role in the fight against many diseases, such as cancer.

This represents a major challenge for pharmaceutical companies that need the right environment and equipment to handle these products, from the process stage through to final packaging, in order to avoid contamination and ensure adequate protection for operators.

The classification system for these products is mainly determined by the value of an index - the Occupational Exposure Limit (OEL) - which defines the maximum tolerable quantity present in a cubic meter during an 8-hour shift. This defines the degree of containment, called the Occupational Exposure Band (OEB), necessary to ensure that these maximum levels are not exceeded during handling by the operator.

In this context Famar Tec has designed and manufactured, in collaboration with FPS, a leading company specialized in containment systems and isolators, the blister machine mod. TF120 for the packaging of oncological products for the Saudi Arabian market, with OEB5 maximum protection level.

Without compromising the usual versatility and ease of use of the machine, particular attention has been paid to operator safety through specific isolation chambers in the product loading, blister sealing and cutting areas. These protections with large windows, besides ensuring maximum visibility of all process operations, are also characterized by special holes equipped with gloves to facilitate maintenance and size changeover operations.

Special ventilation and air filtration systems allow the packaging of the product in a controlled atmosphere. In addition, a negative pressure regime between the inside of the machine and the surrounding environment ensures that all potential contamination is strictly contained in the product handling chamber, allowing safe insertion/extraction of the format parts.