Technology

Steriline Products – A Look at Steriline Isolators

With three decades worth of experience, Steriline is undoubtedly the world’s biggest brand in supplying various pieces of equipment used when packaging injectable drugs. It is, by far, the largest single-source supplier that allows other firms to assemble, manufacture, and supply a diverse assortment of solutions.

It isn’t a premier go-to supplier of equipment solutions for nothing. Steriline’s rich assortment of pharma-oriented items includes those used in mechanical as well as robotics needed in aseptic processing.

About Steriline Isolators

Yet, that Steriline has grown to be to among the world’s leading pharmaceuticals equipment suppliers across the globe is a no-coincidence. This company is specifically revered for its array of uniquely-designed, fully-integrated isolators which all are eligible to be installed in either Class C or D rooms.

All of its isolators aren’t just state-of-the-art and cGMP-compliant; they all are compatible with vials, cartridges, ampoules, and syringes. All Steriline isolators can handle both the toxic and non-toxic substances in whether in liquid form or in as powder. They basically are developed to enable the production of sterile products in clean, safe, and uncompromised conditions.

Another important feature of these isolators is how they are engineered to create the all-important ISO5 environment. With every breeze of HEPA filtered, unidirectional air blowing vertically over the process area, these isolators creates an ISO5 environment.

Each isolator also comes with an exhaust fan which maintains the constant optimal pressure difference between the interior and the exterior. The exhaust hair is passed through BIBO filters.

With these incredible design features, Steriline aseptic filling lines understandably have enormous applications. They serve as washing machines, filling and capping machines and depyrogenation tunnels as well as powerful external decontamination machines and barrier systems.

Tech Know-How Used in Steriline Isolators

What, however, places Steriline far ahead of its competitors is the technology employed in making isolators. Among the main features of Steriline isolators are their soft, smooth stainless steel-made contact surfaces, panels, and guards. All the doors are also made of thick security glass and sealed with inflatable silicone, Viton or EPDM-made gaskets.

Steriline, unlike the rest, also knows and already has a definite market for its products. Being able to design and supply a vast array of entirely, in-house engineered isolators and manufactured ones which also are either in-line or stand-alone is incredible.

Isolators, in a nutshell

Its isolators, in line with cRABS, can be said to be:

  • Engineered to create an IS05 environment.
  • Approved for Level 5 Operator Exposure Band.
  • Automatic pressure control and monitor.
  • Have LED lights.
  • Features PTFE filters.
  • A fully-integrated vaporized H202 generator.
  • A negligible leak rate – a maximum of 2%.
  • Fully cGMP, GAMP, and CFR-21, Part 11 compliant.

Steriline stand-alone isolators are:

  • Tailored to create an ISO5 environment.
  • Approved for Level 5 Operator Exposure Band.
  • Fitted with LED lights.
  • Have PTFE filters.
  • Have integrated vaporized H202 generator.
  • Guarantee a negligible leak rate – less than 2%.
  • Are all cGMP, GAMP and CFR-21, Part 11 compliant

Impressively, all of them are expertly made to allow easy manufacture of sterile products. These particular isolators can manufacture either toxic or non-toxic substances, ensuring constant and uncompromised separation from any external contaminants.

The technology employed in making Steriline Isolators is revolutionary. The isolators combine the manufacturer’s robotic solutions to guarantee top-notch safety standards and production of quality products. All that, for pharmaceutical companies, also means significantly lower production costs and other relevant benefits.

Steriline: Quality and Sustainability

Steriline couldn’t have grown to its current standing where it not for its attention to quality. It earned the prestigious ISO 9001:2008 certification and 2018 ISO 9001:2015 in 2015, an achievement that has rubberstamped its adherence to quality.

The supplier upholds quality in all of its aspects, right from its management systems, especially on production processes, to its overall organizational arrangement. The benefit of having such a framework has been seen with the continued customer satisfaction the company has always been receiving.

Steriline is also fully compliant to all relevant, FDA-enforced cGMP, GAMP and CFR-21, Part 11 requirements. It also places a high emphasis on environmental protection and even employs sustainable production practices in all of its business operations.

In conclusion, Steriline a full complaint of the laid-down legislations on prudent environmental uses that ensures responsible and economically-viable use of resources.

Leave a Reply

Your email address will not be published. Required fields are marked *

CommentLuv badge