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Cleaning Program under the Revised Propositions

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Thursday February 28, 2019

Cleaning Program under the Revised Propositions The proposed revisions to USP <795>, USP <797>, as well as proposed USP <800>, all include sections devoted to cleaning and surface sampling. Proposed/Revised USP <795> defines cleaning as: The process of removing soil (eg, organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically […]

Cleaning Program under the Revised Propositions Read More »

Cleaning Program under the Revised Propositions The proposed revisions to USP <795>, USP <797>, as well as proposed USP <800>, all include sections devoted to cleaning and surface sampling. Proposed/Revised USP <795> defines cleaning as: The process of removing soil (eg, organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically

SOPs for USP Pharmacy

SOPs for USP Pharmacy

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Thursday February 21, 2019

Achieving and maintaining SOPs for USP Pharmacy General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is a continuous effort that requires unremitting attention and maintenance, including staff training, performance review, documentation, and quality improvement efforts. Developing comprehensive policies and procedures (P&Ps) and standard operating procedures (SOPs) is critical to ensuring compliance with the chapter (see TABLE: Recommended

SOPs for USP Pharmacy Read More »

Achieving and maintaining SOPs for USP Pharmacy General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is a continuous effort that requires unremitting attention and maintenance, including staff training, performance review, documentation, and quality improvement efforts. Developing comprehensive policies and procedures (P&Ps) and standard operating procedures (SOPs) is critical to ensuring compliance with the chapter (see TABLE: Recommended

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

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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

Personnel Aseptic Practices Training

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Wednesday January 23, 2019

The primary purpose of cleanroom gowning is to protect the products and the processing environment from human contamination. Cleanroom gowning greatly reduces the microorganisms released by personnel. All personnel should be properly gowning qualified before entering the cleanroom, and the qualification should be performed by a trained analyst. The degree of gowning should get more

Personnel Aseptic Practices Training Read More »

The primary purpose of cleanroom gowning is to protect the products and the processing environment from human contamination. Cleanroom gowning greatly reduces the microorganisms released by personnel. All personnel should be properly gowning qualified before entering the cleanroom, and the qualification should be performed by a trained analyst. The degree of gowning should get more

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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