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Aseptic Enclosures – Compounding Solutions

In case you missed the presentation we did a few days ago on "How to get a clean-room designed, built, and certified in less than 5 months

How to Get a Clean-room Designed, Built and Certified in Less than 5 Months

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Monday January 11, 2021

In case you missed the presentation we did a few days ago on “How to get a clean-room designed, built, and certified in less than 5 months which will have a ‘Plug and Play’ feature for permanent or temporary installations “, we now have the recordings available for on-demand review. In this presentation, we review the […]

How to Get a Clean-room Designed, Built and Certified in Less than 5 Months Read More »

In case you missed the presentation we did a few days ago on “How to get a clean-room designed, built, and certified in less than 5 months which will have a ‘Plug and Play’ feature for permanent or temporary installations “, we now have the recordings available for on-demand review. In this presentation, we review the

Compounding Capabilities during Cleanroom Renovations

Compounding Capabilities during Cleanroom Renovations

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Wednesday December 23, 2020

When renovating a cleanroom, or creating one from non-cleanroom space, understanding the details — of the site, building, planned research, and equipment — is essential. Cleanrooms are like race cars. When properly designed and built, they are highly efficient performance machines. When poorly designed and built, they operate poorly and are unreliable. The cost of cleanroom varies

Compounding Capabilities during Cleanroom Renovations Read More »

When renovating a cleanroom, or creating one from non-cleanroom space, understanding the details — of the site, building, planned research, and equipment — is essential. Cleanrooms are like race cars. When properly designed and built, they are highly efficient performance machines. When poorly designed and built, they operate poorly and are unreliable. The cost of cleanroom varies

pass through chamber

WHAT IS A PASS THROUGH CHAMBER?

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Wednesday December 2, 2020

The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area.

WHAT IS A PASS THROUGH CHAMBER? Read More »

The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area.

Compounding Capabilities during Cleanroom Renovations

How should We Keep Cleanrooms Clean?

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Wednesday November 25, 2020

Controlling microbial ingress into the cleanroom is a critical concern for the entire cleaning and disinfection process. Components, personnel, carts, tanks, tools, cleaning supplies, and instruments that are transferred into the clean area should be clean and free of contamination. Cross contamination is easier to prevent than to correct.

How should We Keep Cleanrooms Clean? Read More »

Controlling microbial ingress into the cleanroom is a critical concern for the entire cleaning and disinfection process. Components, personnel, carts, tanks, tools, cleaning supplies, and instruments that are transferred into the clean area should be clean and free of contamination. Cross contamination is easier to prevent than to correct.

Aseptic Compounding

Excluding Contamination in Aseptic Compounding

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Wednesday November 4, 2020

Steroids for epidural delivery were found to be contaminated with fungal spores leading to over 700 reported cases of meningitis and 64 deaths.

Excluding Contamination in Aseptic Compounding Read More »

Steroids for epidural delivery were found to be contaminated with fungal spores leading to over 700 reported cases of meningitis and 64 deaths.

sterile compounding

Sterile Compounding USP 797 Solutions

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Wednesday October 14, 2020

  Sterile compounding is an essential element of patient care. Hospitals and clinics need to evaluate the best way to optimize care and meet regulatory and safety requirements while managing the costs of these important medicines. Our team of experts can help you evaluate external sources and the opportunity and requirements of insourcing this critical

Sterile Compounding USP 797 Solutions Read More »

  Sterile compounding is an essential element of patient care. Hospitals and clinics need to evaluate the best way to optimize care and meet regulatory and safety requirements while managing the costs of these important medicines. Our team of experts can help you evaluate external sources and the opportunity and requirements of insourcing this critical

Preventing Contamination In Compounding Facilities

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Wednesday January 30, 2019

Compounding pharmacies come in many different shapes and sizes. They can consist of a pharmacist creating a drug under a doctor’s prescription or they can be pharmacy-type facilities that compound drugs and sell them like a manufacturer. Sporadic and serious infection outbreaks have been linked to compounding pharmacies outside of the hospital setting.1 These problems date

Preventing Contamination In Compounding Facilities Read More »

Compounding pharmacies come in many different shapes and sizes. They can consist of a pharmacist creating a drug under a doctor’s prescription or they can be pharmacy-type facilities that compound drugs and sell them like a manufacturer. Sporadic and serious infection outbreaks have been linked to compounding pharmacies outside of the hospital setting.1 These problems date

Updated Guidance for Compounding Facilities 503B

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Wednesday January 9, 2019

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and

Updated Guidance for Compounding Facilities 503B Read More »

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and

Can an Isolator still be used without a Cleanroom?

Can an Isolator still be used without a Cleanroom?

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Wednesday December 19, 2018

Can an Isolator still be used without a Cleanroom? The answer is complicated. Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions. Usually, the certifier will conduct particle tests and airflow studies while a

Can an Isolator still be used without a Cleanroom? Read More »

Can an Isolator still be used without a Cleanroom? The answer is complicated. Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions. Usually, the certifier will conduct particle tests and airflow studies while a

Compounding Capabilities during Cleanroom Renovations

The Risks of Automated Compounding of IV Products

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Wednesday September 12, 2018

The last couple of years we have recorded a serious upswing and increase of use of automated IV preparation systems. Their popularity is directly linked to their ease of use since they combine barcode scanning and Digital image capture to ensure safer and more efficient compounding processes. With the increase of use of such technology

The Risks of Automated Compounding of IV Products Read More »

The last couple of years we have recorded a serious upswing and increase of use of automated IV preparation systems. Their popularity is directly linked to their ease of use since they combine barcode scanning and Digital image capture to ensure safer and more efficient compounding processes. With the increase of use of such technology

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Aseptic Enclosures located in St Louis, Missouri manufactures a wide range of Air Filtration equipment for Aseptic processing and Containment applications.

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