OSD manufacturing facilities must ensure the highest levels of product quality and operator safety.
The primary objective of international regulatory requirements for OSD manufacturing facilities is to protect pharmaceutical products and guarantee the highest product quality. Equally important, processes carried out within the facility must be streamlined and increasingly focused on safeguarding operator safety. CSV Containment is highly attuned to the specific needs of each OSD facility and is frequently called upon to assess the processes conducted within to enhance their safety. One of the most widely adopted and adaptable protective measures for equipment is the flexible isolator, a field where we have extensive expertise.
Setting the Stage.
Before beginning the design of an isolation solution for the components of an OSD facility, it is essential to determine the desired containment level and the procedures to be performed on each piece of equipment.
A flexible isolator must not only operate during standard machine processes, such as coating or tableting, but also support activities like preparation, maintenance, and cleaning. Each of these operations requires dedicated space and specific movements, meaning the design of the bag encasing the equipment must account for various factors.
The Ease of Change.
This must be an easy task. Replacing consumable parts of an isolator must be straightforward, minimizing complexity and downtime. For this reason, CSV Containment’s isolators are equipped with quick-release systems featuring buttons and loops, enabling them to be quickly fitted to the metal framework.
New functional spaces can be created even in compact environments. For example, chambers equipped with multiple gloves enable operators to access every part of the machine comfortably—whether loading capsules, opening protective covers on a tablet press, or working around a coating machine. The use of disposable butterfly valves, bags, sleeves, and continuous liners ensures that all operator requirements are met, effectively streamlining their workflows.
Virtuality as a Function of Reality.
Each process platform involves specific operations, configurations, and subprocesses, which contribute to increasing overall complexity. Modern facilities often aim to minimise their footprint while maximising efficiency. This requires working with equipment fitted with isolators designed with precise dimensions, ergonomic access points, and film materials that ensure excellent visibility.
To meet these demands, we frequently develop mock-ups that enable clients to perform remote testing of future isolators via streaming, ensuring optimal solutions even from a distance.
CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: containment@csv-ls.com
