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Aseptic Enclosures – Blog

New Definition for Sterile Compounding

manufacturing of sterile products is the most critical and difficult type of compounding. The whole chapter was open for public comments during September. We managed to get our hands on a non-paper that has been submitted from the USP. The new law Defines “sterile compounding” as compounding drug products for injection, inhalation or administration in […]

New Definition for Sterile Compounding Read More »

manufacturing of sterile products is the most critical and difficult type of compounding. The whole chapter was open for public comments during September. We managed to get our hands on a non-paper that has been submitted from the USP. The new law Defines “sterile compounding” as compounding drug products for injection, inhalation or administration in

VA Publishes their Pharmacy Design Guide

Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these

VA Publishes their Pharmacy Design Guide Read More »

Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these

Don’t Stop Production for Cleanroom Renovation

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

Don’t Stop Production for Cleanroom Renovation 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

Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products

  guidelines on quality assurance for pharmacy prepared sterile products that can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion. Hospitals use a

Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products Read More »

  guidelines on quality assurance for pharmacy prepared sterile products that can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion. Hospitals use a

USP 800 Checklist: Priority Areas to Address

  To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.   Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting. This could include: Outsourcing high-volume CSPs to 503B facilities

USP 800 Checklist: Priority Areas to Address Read More »

  To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.   Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting. This could include: Outsourcing high-volume CSPs to 503B facilities

Three things to consider when upgrading to meet USP 800

Pharmacies around The United States are in various stages of planning and implementing facility and operational changes to meet the requirements of USP 800. The mile markers are slipping by, but wherever you are on the road to compliance, we helped out by listing the 3 most important steps in achieving USP Compliance.    

Three things to consider when upgrading to meet USP 800 Read More »

Pharmacies around The United States are in various stages of planning and implementing facility and operational changes to meet the requirements of USP 800. The mile markers are slipping by, but wherever you are on the road to compliance, we helped out by listing the 3 most important steps in achieving USP Compliance.    

Pharma D Solutions voluntarily recalls all sterile compounded drugs

All sterile compounded drug products from Pharma D Solutions are being voluntarily recalled due to a potential contamination risk at the pharmacy, according to a company press release. The drugs affected by the recall include any compounded at the pharmacy within the past 12 months, which were distributed nationwide and directly to customers and medical

Pharma D Solutions voluntarily recalls all sterile compounded drugs Read More »

All sterile compounded drug products from Pharma D Solutions are being voluntarily recalled due to a potential contamination risk at the pharmacy, according to a company press release. The drugs affected by the recall include any compounded at the pharmacy within the past 12 months, which were distributed nationwide and directly to customers and medical

The Risks of Automated Compounding of IV Products

The Risks of Automated Compounding of IV Products

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

Reducing Risks of Exposure to Hazorduous drugs

Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving. Under the current regulations as well as the upcoming USP <800> the hazardous materials are usually ordered

Reducing Risks of Exposure to Hazorduous drugs Read More »

Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving. Under the current regulations as well as the upcoming USP <800> the hazardous materials are usually ordered

What is USP ?

  Whenever new standards or regulations are put in place, it’s important to understand who developed them, what they are, and why they were developed.  The goal of the United States Pharmacopoeia (USP), the organization behind USP <800>, is “to improve global health through public standards and related programs that help ensure the quality, safety,

What is USP ? Read More »

  Whenever new standards or regulations are put in place, it’s important to understand who developed them, what they are, and why they were developed.  The goal of the United States Pharmacopoeia (USP), the organization behind USP <800>, is “to improve global health through public standards and related programs that help ensure the quality, safety,