Aseptic Isolators: Operator and Product Protection Systems

Industrial processing equipment with multiple circular windows and control panel, designed for a controlled environment and precise operations.

In the pharmaceutical industry, the challenge of maintaining sterility and preventing contamination during the manufacturing process is paramount. Aseptic manufacturing, which involves producing sterile products without the use of heat sterilization, presents a significant challenge for pharmaceutical manufacturers. Any microbial contamination can have serious consequences, from reducing product efficacy to compromising patient safety.

At our company, we recognize the importance of aseptic manufacturing and provide tailored solutions to help our customers meet this challenge. Our range of micronization systems and isolators are designed to maintain a sterile environment during the manufacturing process. We offer a variety of solutions, including steam, VHP, or others, based on the specific requirements of our customers.

For sterile micronization, we use jet milling systems that are designed to be positioned in a controlled environment, whether it is a Class A isolator in a Class C room or a jet mill specifically designed for manufacturing in a Class A room. These jet mills are designed to be sterilized using autoclave, SIP or VHP.

Learn more about Aseptic Isolators

We offer three possible set-ups for our customers:

Case 1: Class B/A Room with open jet mill - In this setup, the jet mill is positioned in a Class B or A cleanroom, and the product is fed into the jet mill through a sterile connection. The jet mill is open and not enclosed within an isolator.

Case 2: Class C/D room without glove box - In this setup, the jet mill is positioned in a Class C or D cleanroom, and the product is fed into the jet mill through a sterile connection. The jet mill is not enclosed within an isolator, but the cleanroom environment is controlled to prevent contamination.

Case 3: Class C/D room with glove box - In this setup, the jet mill is positioned in a Class C or D cleanroom and is enclosed within a glove box isolator. The product is fed into the jet mill through a sterile connection.Our aseptic isolators and micronization systems are designed to meet the most stringent regulatory requirements and provide our customers with a reliable and efficient solution for their aseptic manufacturing needs. Contact us today to learn more about our tailored solutions for aseptic manufacturing.