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2019

Basic Cleanroom Protocol - Hospital Industry News

Basic Cleanroom Protocol

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Wednesday April 17, 2019

Basic cleanroom protocol programs are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the […]

Basic Cleanroom Protocol Read More »

Basic cleanroom protocol programs are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the

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

Cleaning Program under the Revised Propositions

Leave a Comment / Blog, Contamination Control, FDA News, Infection Control, Research News /

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

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

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

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