Talking about the isolator VS "open" biological safety cabinet

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Primary Engineering Control (PEC) is strongly recommended for use in the preparation of sterile preparations (CSP). A device or room in which PEC can provide an ISO Class 5 or Class A cleanliness level in a composite sterile formulation. Even when used as a room, it is a standard certified device.

PEC relies on high efficiency air (HEPA) filters to maintain ISO 5 clean air. The HEPA filter has a retention efficiency of up to 99.995% for particles of 0.3 microns. The HEPA-filtered unidirectional gas stream has sufficient wind speed to remove particles from the direct composite zone and maintain one-way flow of the gas stream as the composite sterile formulation is maintained

There are many PECs in sterile drug synthesis. Their suitability depends on the type of CSP being prepared.

CSP type

Non-hazardous

Risk

Example

Total parenteral nutrition, ophthalmic preparation, central IV admixture

Antineoplastic agents, hormones, antibody drug complexes

Target/second

1. Protect products from microbes and cross-contamination

1. Protect products from microbes and cross-contamination
2. Protect people and the environment from these hazards.

Page

1. Ultra-clean workbench
2. Secondary biological safety cabinet
3. Sterile isolators (CAIs)
3. Positive pressure isolator

1. Cytotoxic drug safety cabinet
2. Secondary biological safety cabinet
3. Sterile Containment Isolation (CACI)
4. Negative pressure isolator

“The correct placement of the PEC is also critical. The equipment should be placed properly, otherwise contaminants may be introduced into the CSP you are compounding.”

Isolators generally provide better protection than "open" cabinets. The ability of an “open” biosafety cabinet to maintain an ISO 5 environmental rating depends to a large extent on the placement of a cabinet 2 operator technology 3 environmental factors

However, the isolator is not susceptible to the above factors.

As a world-class manufacturer of clean equipment, Esco has a wide range of biosafety cabinets to meet your application needs. We also offer a wide range of isolators for the pharmaceutical industry to provide superior isolation. performance,

Esco is always committed to providing you with a better choice!

For more information on biosafety cabinets and isolators, please contact Esco China or your local distributor!

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