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Sterile Compounding Outsourcing Benefits, Considerations, and Regulatory Compliance

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Tuesday July 11, 2023

Sterile compounding is a critical aspect of pharmaceutical care, ensuring the availability of customized medications for patients with unique needs. However, the increasing complexity and regulatory requirements of sterile compounding have prompted many healthcare institutions and pharmacies to explore outsourcing options. This article delves into  Compounding Outsourcing Benefits, considerations, and regulatory compliance, providing insights to […]

Sterile Compounding Outsourcing Benefits, Considerations, and Regulatory Compliance Read More »

Sterile compounding is a critical aspect of pharmaceutical care, ensuring the availability of customized medications for patients with unique needs. However, the increasing complexity and regulatory requirements of sterile compounding have prompted many healthcare institutions and pharmacies to explore outsourcing options. This article delves into  Compounding Outsourcing Benefits, considerations, and regulatory compliance, providing insights to

counterfeit drugs

SERIALIZATION, TRACK & TRACE AND COUNTERFEIT DRUGS: A DETAILED OVERVIEW

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Saturday January 28, 2023

How counterfeit drugs effect pharmacuticals Challenges posed by counterfeit drugs to the pharmaceutical industry have affected the market share and raised health concerns among health professionals, Legislators, and suppliers. Internet marketing plays a pivotal role in dominating fake drugs over genuine ones. In addition, at various levels of the supply chain processes, high prospects of

SERIALIZATION, TRACK & TRACE AND COUNTERFEIT DRUGS: A DETAILED OVERVIEW Read More »

How counterfeit drugs effect pharmacuticals Challenges posed by counterfeit drugs to the pharmaceutical industry have affected the market share and raised health concerns among health professionals, Legislators, and suppliers. Internet marketing plays a pivotal role in dominating fake drugs over genuine ones. In addition, at various levels of the supply chain processes, high prospects of

chemotherapy clinics and pregnancy risks

The Impact of Cancer Radiation Therapy on Pregnancy in Healthcare Workers

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Wednesday February 3, 2021

Radiation therapy has revolutionized cancer treatment, providing hope to millions of patients worldwide. However, it also poses unique challenges for healthcare workers, especially those who are pregnant. This article aims to delve deeper into the effects of radiation exposure on pregnancy and explore comprehensive safety measures that healthcare institutions can implement to protect pregnant employees.

The Impact of Cancer Radiation Therapy on Pregnancy in Healthcare Workers Read More »

Radiation therapy has revolutionized cancer treatment, providing hope to millions of patients worldwide. However, it also poses unique challenges for healthcare workers, especially those who are pregnant. This article aims to delve deeper into the effects of radiation exposure on pregnancy and explore comprehensive safety measures that healthcare institutions can implement to protect pregnant employees.

Exposure to Hazardous Materials

Exposure to Hazardous Materials during Shipping and Receiving

Leave a Comment / Blog, Company News, Compounding News, Contamination Control, Engineering Controls, Hospital Industry News, Pharmaceutical Industry News, Research News /

Wednesday December 16, 2020

Whether isolator or cleanroom-based working areas, if we’re talking about both sterile and hazardous sterile preparations we recognize the first source of Exposure To Hazardous Materials . The first known is actually outside of the cleanroom and is the pre-cleaning station. In the hazardous drug area, we like to see packages from shipping and receiving brought

Exposure to Hazardous Materials during Shipping and Receiving Read More »

Whether isolator or cleanroom-based working areas, if we’re talking about both sterile and hazardous sterile preparations we recognize the first source of Exposure To Hazardous Materials . The first known is actually outside of the cleanroom and is the pre-cleaning station. In the hazardous drug area, we like to see packages from shipping and receiving brought

ViTralizer – Virus Neutralizing System

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Tuesday October 20, 2020

ViTralizer – Technology that’s clinically proven to kill viruses such as COVID-19 and Flu. “Greatly reduce infection risk!” “Sanitize any public, residential, or office area.” Using the “ViTralizer” allows you to easily sanitize and make the space far safer for your families, clients, employees, patients, passengers, etc. A great advantage of our system is its

ViTralizer – Virus Neutralizing System Read More »

ViTralizer – Technology that’s clinically proven to kill viruses such as COVID-19 and Flu. “Greatly reduce infection risk!” “Sanitize any public, residential, or office area.” Using the “ViTralizer” allows you to easily sanitize and make the space far safer for your families, clients, employees, patients, passengers, etc. A great advantage of our system is its

503 b compounding pharmacy

Revised 503 b compounding pharmacy guidance

1 Comment / Blog, Company News, Compounding News, Hospital Industry News, Pharmaceutical Industry News, Research News /

Tuesday September 15, 2020

According to the Federal Register Notice that announced the 503 b compounding pharmacy revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities

Revised 503 b compounding pharmacy guidance Read More »

According to the Federal Register Notice that announced the 503 b compounding pharmacy revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities

ViTralizer - Virus Neutralizing System

Basic Cleanroom Protocol

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

Tuesday September 15, 2020

Most of the typical cleanroom protocols 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 focal point of any protocol program is to protect the integrity of the cleanroom, the products, and processes

Basic Cleanroom Protocol Read More »

Most of the typical cleanroom protocols 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 focal point of any protocol program is to protect the integrity of the cleanroom, the products, and processes

Basic Cleanroom Protocol

Basic Cleanroom Protocol

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

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

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

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

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

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

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