A deep dedication to manufacturing excellent, high-quality goods and outstanding customer gratification is our number one priority. The metering and dispensing systems that Ivek creates offer exceptional general performance and reliability for by far the most demanding applications.
This adaptability contributes to enhanced creation versatility, enabling pharmaceutical companies to respond immediately to marketplace requires and altering merchandise requires.
By adhering to stringent hygiene criteria, these machines safeguard item integrity and be certain that remedies are Risk-free for use.
Regardless of the issues linked to preserving aseptic disorders for your manufacture of these novel biologics, these merchandise are very at risk of microbial contamination as a result of guide manipulations associated with their manufacturing.
The ceramic components Utilized in these methods are extremely hard and resist abrasion. Ivek metering and dispensing devices demonstrate minor to no put on, even soon after a huge selection of an incredible number of cycles. Dedicated to Outstanding High quality and Customer care
The Set up Qualification approach for almost any FFS system should really affirm and certify the room conforms to the desired Environmental Normal. A completely new cleanroom installation must include: room air filter integrity checks; perseverance of air velocity in the face of each and every air inlet filter; area air transform fee; air particle counts, each practical and non-viable, in the rest condition; area force differentials; and lights, heating and humidity readings.
The regulatory assistance endorses that FFS machinery and its bordering boundaries be built to prevent the prospective for extraneous contamination.
Price tag efficiencies are driving increased usage of FFS in liquid parenteral drug packaging, but consideration to procedure parameters, testing and validation is critical
Terminal sterilization includes filling and sealing containers beneath unique environmental circumstances to circumvent the contamination of such solutions from microbial and particulate matter.
The manufacturing of each sterile medication and Organic goods is usually reached as a result of terminal sterilization or aseptic processing.
Handbook filter integrity examination shall not be more info utilised. Filter examination shall be performed employing equipment, and testing benefits should be immediately saved and printed. No guide recording of The end result.
On top of that, the automated character of liquid bottle filling equipment performs an important part in optimizing useful resource allocation and decreasing labor requirements. By streamlining the filling approach and minimizing the need for guide intervention, these equipment enhance operational effectiveness and efficiency.
When producing a sterile merchandise, persons usually do not fully grasp what’s required to manufacture the products. Does the molecule call for aseptic filling, or can it's terminally sterilized?
AbbVie's mission is to discover and supply revolutionary medicines and methods that solve major health problems currently and address the clinical difficulties of tomorrow. We try to possess website a outstanding effect on people today's life across various key therapeutic places – immunology, oncology, neuroscience, and eye treatment – and services in our Allergan Aesthetics portfolio.