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Ensuring compliance with USP

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Wednesday April 10, 2019

Ensuring compliance with USP Chapters is a significant concern in the field of sterile compounding, particularly for small and rural facilities. This process can be both daunting and expensive, especially when managing multiple large projects simultaneously. The division of focus among these projects poses a risk of negatively impacting the desired end goals. To tackle […]

Ensuring compliance with USP Read More »

Ensuring compliance with USP Chapters is a significant concern in the field of sterile compounding, particularly for small and rural facilities. This process can be both daunting and expensive, especially when managing multiple large projects simultaneously. The division of focus among these projects poses a risk of negatively impacting the desired end goals. To tackle

Developing a Robust Compounding Strategy

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Wednesday March 27, 2019

  Developing a Robust Compounding Strategy is critical to ensuring patients have access to properly compounded medications, but because each organization’s needs differ, a one-size-fits-all solution cannot be applied to every hospital. A careful evaluation of the institution’s requirements, the available infrastructure for compounding medications in-house, and any registered 503B compounding facilities in the vicinity

Developing a Robust Compounding Strategy Read More »

  Developing a Robust Compounding Strategy is critical to ensuring patients have access to properly compounded medications, but because each organization’s needs differ, a one-size-fits-all solution cannot be applied to every hospital. A careful evaluation of the institution’s requirements, the available infrastructure for compounding medications in-house, and any registered 503B compounding facilities in the vicinity

Preventable Workplace Hazards

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Thursday March 14, 2019

The degree of danger that pharmacy workers are subject to depends on the kind of pharmacy they work in and its location. Pharmacists can be employed in community-, retail-, and hospital-based pharmacies, among others. Each of these workplace settings brings different hazards that need to be addressed to prevent harm. 1. Biological HazardsContact with patients

Preventable Workplace Hazards Read More »

The degree of danger that pharmacy workers are subject to depends on the kind of pharmacy they work in and its location. Pharmacists can be employed in community-, retail-, and hospital-based pharmacies, among others. Each of these workplace settings brings different hazards that need to be addressed to prevent harm. 1. Biological HazardsContact with patients

Trends in USP Compliance

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Wednesday February 13, 2019

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting

Trends in USP Compliance Read More »

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting

Preventing Contamination In Compounding Facilities

1 Comment / Blog, Compounding, Compounding News, Compounding Solutions, Contamination Control /

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?

1 Comment / Blog, Company News, Compounding News, Compounding Solutions, Engineering Controls, FDA News, Hospital Industry News, Pharmaceutical Industry News, Research News /

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

Cleanroom Training and Evaluation

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Wednesday December 12, 2018

As cleanroom experts, we also provide on-site clean room training.   This on-site training can be implemented in several ways. We have done short courses, that largely involves lecture only in as little as one day on-site. Depending on the number of people, a full training and testing class can take as long as two

Cleanroom Training and Evaluation Read More »

As cleanroom experts, we also provide on-site clean room training.   This on-site training can be implemented in several ways. We have done short courses, that largely involves lecture only in as little as one day on-site. Depending on the number of people, a full training and testing class can take as long as two

Cleanrooms and Space Constraints

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Wednesday November 28, 2018

In the cleanroom world, the space that you are willing to allocate to your clean operations is what you will have for the next couple of years. Making the right decision is hard, costly and requires a lot of thinking before committing to any solution. What we think is the best starting point is deciding

Cleanrooms and Space Constraints Read More »

In the cleanroom world, the space that you are willing to allocate to your clean operations is what you will have for the next couple of years. Making the right decision is hard, costly and requires a lot of thinking before committing to any solution. What we think is the best starting point is deciding

Submit Your Last Comments to USP 797 Revisions

Leave a Comment / Blog, Company News, Compounding News, FDA News, Hospital Industry News, Pharmaceutical Industry News, Research News /

Wednesday November 21, 2018

  Next Friday, November 30th, The USP 797 closes for public commenting. There is still plenty of time for more comments to be made. All comments should be submitted via the <797> web page, no later than November 30, 2018. A lot of questions and points were made during the open mic session on the USP

Submit Your Last Comments to USP 797 Revisions Read More »

  Next Friday, November 30th, The USP 797 closes for public commenting. There is still plenty of time for more comments to be made. All comments should be submitted via the <797> web page, no later than November 30, 2018. A lot of questions and points were made during the open mic session on the USP

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