Pharma companies focus on quality at the beginning of the manufacturing process to ensure against defects and normally employ a quality risk management program to identify critical parameters or conditions that could affect product quality and patient safety, often incorporating operational controls to mitigate or reduce the probability of their occurrence. The principal objective is to determine where particulates are most likely to enter the process, i.e. which are the steps within the end-to-end manufacturing process that are most critical to particle generation and how to control the risk of particle generation.
Managing these risks, though, requires the implementation of a safety program as well as advanced technologies, the use of flexible equipment and proper containment solutions for environmental control.
INJECTA robotic technology offers a means to complete many routine tasks more swiftly, accurately and intelligently, accelerating routine processes and ensuring there are no barriers to agility. INJECTA is beyond doubt an example of how the use of appropriate technology and process automation bring process efficiencies and quality priorities in line.
#Quality Enhancement is Ground-breaking Sterile Outer Bag Handling.
Controlled barriers, containment measures of pressure differentials and protective airflow applied together with advanced robotic handling all help preserve the sterility of the tub (and its components) during outer bag opening procedures. To meet the regulatory requirements, the whole tub-opening unit is completely robotized and under containment. Bag opening is performed in a way that minimises contamination risks, at a point where airflow and pressure difference between two sections ensure the tub remains sterile. After cutting the bag overwrapped around the tub, the primary package is instantly transferred by an internal transfer port to the isolated, processing area.
INJECTA’s robotic technology is a key contribution to preserving tub sterility.
To preserve the sterility of the tub, the bag flaps are opened by suction cups, only when the tub is physically transferred to the isolated area. This innovative pass-through solution helps minimize the exposure of tub and relevant components in less restrictive areas to particles originating from primary packaging materials and/or other routes of particle introduction, improving process quality.
#Quality Enhancement is 100% In-line Process Control with Single Non-conformity Rejection.
INJECTA’s robotic system provides flexibility, ease of use, and sterility assurance enabling a real-time fill-weight check and ensuring the greatest quality result by a single-component rejection system.
INJECTA can easily combine fully robotized 100% check-weighing, while ensuring top-notch machine performance.
All processed RTU components are individually check-weighed (in case of de-nesting) or check-weighed all together while in nest, with single rejection of each individual non-conformity, safeguarding the nest.
INJECTA ensures single rejection both from the nest or with de-nesting.
A patented device used to eliminate the electrostatic charge in the nest is the first step towards accurate weighing, handled by a system designed to minimise interference in weighing accuracy caused by airflow.As a de-nesting solution, INJECTA’s flexible handling units allow for precise removal of the components from the nest. Individual components (1 or 2, or 5-6 at a time) are filled, check-weighed, immediately stoppered, meaning the sterile drug product is subject to much shorter exposure times within the aseptic environment. The design of the 5/6 weigh-cell block also allows for the tolerance required to manage different RTU component formats.
#Quality Enhancement is Maximum Cleansability.
Smaller batches, high potency products such as biologics or conjugates and therapies, involving genes and cells to combat cancer indications, involve the implementation of proper cleansing procedures to avoid or isolate contamination from process areas. INJECTA’s design allows for easy pass-through and cleansing procedures, which are mandatory when handling potent compounds, ensuring the safety and the integrity of the products.
Equipment design, also featuring a massive presence of robots, facilitates protection of open containers thanks to unidirectional airflow.
The overwhelming presence of robots entails the total absence of conventional transfer combs or conveyor belts, facilitating unidirectional airflow (avoiding barriers). Furthermore, INJECTA’s concept design supports proper wash-in-place (WIP) cleansing processes, removing internal surface contaminants from the machine. Surface design facilitates more effective cleaning procedures. Ensuring potential contamination is kept to a strict minimum means greater protection for the product, the equipment itself and the staff operating the equipment or attending to cleaning procedures.