steriline_stand-alone-isolators_luglio-pdf

STERILINE_Stand-Alone-Isolators_Luglio.pdf

The word parenteral comes from Greek and means outside the intestine (para=outside and enteron=intestine). In fact, when it comes to parenterals, we are referring to those dosage forms that are administered directly into the bloodstream using a hypodermic needle, avoiding going through the gastrointestinal tract. Using parenteral filling equipment, parenteral solutions are placed in containers such as vials, syringes, or ampoules.

Parenterals

Designed for lab and R&D work, with small footprint and lightweight design

ISO5 environment with HEPA filtration on supply and exhaust

  Easy to operate and maintain, with intuitive touchscreen HMI

Fully compliant with all relevant cGMP, GAMP and 21CFR Part11 requirements

Barrier isolator systems create a physical and an aerodynamic barrier between the operator and the work process. The product or process inside the isolator can only be manipulated through the use of gloves or a robotic arm. Choosing an isolation system involves considering the safety regulations (for example; operator protection or cGMP standards), positive or negative pressure specifications, and monitoring and control requirements. Barrier and isolator systems are used in the pharmaceutical industry for sterile processes such as injectable drug filling and cytotoxic drug compounding. Barrier systems and isolators are integrated into full production lines and the most important thing is to control and monitor airflow.

Containment isolators

Pharmaceutical

The essential objectives of containment systems are personnel protection and preventing the release of toxic or infectious material into the environment. Containment is also used to prevent a product or sample from contamination by the external environment. In the chemical and pharmaceutical industries, containment solutions are used to protect the personnel from the leaking of airborne particles of hazardous substances, as powders or liquids are handled or transferred during processing.

Containment

Biopharmaceuticals are drugs in which the active substance is manufactured or extracted from biological origin materials. They are usually produced in bioreactors by plant cells, microbial cells, yeast cultures, or mammalian cells. Also known as biomanufacturing, they are used to either treat or diagnose and prevent a patient’s medical condition or disease. Biopharmaceuticals are typically complex macromolecules administered by injection or infusions, and examples include vaccines, serums, and insulin.

Biopharmaceuticals

Pharmaceutical developments walk side by side with health advances to provide new medicines, treatments, and therapies that have increased life quality and extended life expectancy by years. Pharmaceutical manufacturing equipment helps deliver products to a great deal of the population, but there’s a significant share that doesn’t benefit from them yet. Over 2 billion people cannot get the medicines they need, according to the United Nations Industrial Development Organization, and local production might be a way to provide for these people.

Pharmaceuticals

Packaging

Process

R&amp;D

Batch

Continuous

liquid

solid

Bespoke aseptic isolators designed for production environments don’t meet the needs of small-scale uses. For compounding, quality control, sterility

Compounding aseptic isolator - Making.com

https://making-tst.imgix.net/2018/10/Steriline-851_Stand-alone-Isolator.jpg

Home

Compounding aseptic isolator

The marketplace for finding innovative production technology

Making.com

https://making-tst.imgix.net/2022/12/makingCopy.png

Privacy Policy

User Agreement

Terms of Service

Default Confirmation

If too long

This form auto replies from Zendesk on submission
on Trigger ID: tbc
https://vekamafsupport.zendesk.com/agent/admin/triggers

Compounding aseptic isolator

Standalone Isolator for lab and QC use

Benefits

Downloads