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Updated Compounding Rules Could Affect Cleanroom Design

  While all three chapters address cleanrooms, USP <795> is the first (of two) to have its revisions made public and, accordingly, provides facility owners with the first opportunity to provide public comment or seek clarification. Section four of the Proposed Revision to GC <795>, which covers Buildings and Facilities, states: Compounding facilities must have […]

Updated Compounding Rules Could Affect Cleanroom Design Read More »

  While all three chapters address cleanrooms, USP <795> is the first (of two) to have its revisions made public and, accordingly, provides facility owners with the first opportunity to provide public comment or seek clarification. Section four of the Proposed Revision to GC <795>, which covers Buildings and Facilities, states: Compounding facilities must have

503B Audits and Services

        Under the FCDA Act, outsourcing facilities register with, and are regulated and inspected by FDA as 503B outsourcing facilities. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP

503B Audits and Services Read More »

        Under the FCDA Act, outsourcing facilities register with, and are regulated and inspected by FDA as 503B outsourcing facilities. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP

USP Compounding General Chapters Now Available for Public Comment

USP Compounding General Chapters are now available for public comment. The USP team has scheduled an Open Microphone session for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.   To register please follow this link

USP Compounding General Chapters Now Available for Public Comment Read More »

USP Compounding General Chapters are now available for public comment. The USP team has scheduled an Open Microphone session for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.   To register please follow this link

Time to Start your Compliance process

Start your Compliance process with all the current compounding regulations can seem like a steep hill to climb for health facilities professionals. Trying to understand all of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies

Time to Start your Compliance process Read More »

Start your Compliance process with all the current compounding regulations can seem like a steep hill to climb for health facilities professionals. Trying to understand all of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies

Choosing Engineering Controls Under USP 800

The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer these

Choosing Engineering Controls Under USP 800 Read More »

The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer these

StageThru 800

The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area. This equipment is designed to provide a protective barrier for the operator.  It is not iso-classified.  It

StageThru 800 Read More »

The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area. This equipment is designed to provide a protective barrier for the operator.  It is not iso-classified.  It

Schedule Your On-site Facility Evaluation

Schedule Your On-site Facility Evaluation Last chance to set up an on-site meeting with our Pharmacy Projects Manager. Joe Skorcz will be on tour in the Minneapolis area performing visits for Aseptic Enclosures’ pharmacy design evaluations. If interested in scheduling a meeting and having our Engineer come and evaluate your facility’s day to day operations

Schedule Your On-site Facility Evaluation Read More »

Schedule Your On-site Facility Evaluation Last chance to set up an on-site meeting with our Pharmacy Projects Manager. Joe Skorcz will be on tour in the Minneapolis area performing visits for Aseptic Enclosures’ pharmacy design evaluations. If interested in scheduling a meeting and having our Engineer come and evaluate your facility’s day to day operations

XLTC800 for Tablet Pressing

  Here in Aseptic Enclosures we have encountered a project where we were called upon to come up with a solution that will provide ISO class 5 conditions for compounding tablets. The issues we had successfully overcome were: increasing safety of the pharmacist, assuring sterility of the product, limit particulate emissions and avoid risks for

XLTC800 for Tablet Pressing Read More »

  Here in Aseptic Enclosures we have encountered a project where we were called upon to come up with a solution that will provide ISO class 5 conditions for compounding tablets. The issues we had successfully overcome were: increasing safety of the pharmacist, assuring sterility of the product, limit particulate emissions and avoid risks for

Pharmacy Planning and Design Projects

  When it comes to clean room design, fabrication, installation, pricing, and customer service, we do clean rooms right. Whatever you’re looking for in a clean room, from economical soft wall installations to the top of the line hard wall construction for permanent use, our clean room value is second to none. We sell our

Pharmacy Planning and Design Projects Read More »

  When it comes to clean room design, fabrication, installation, pricing, and customer service, we do clean rooms right. Whatever you’re looking for in a clean room, from economical soft wall installations to the top of the line hard wall construction for permanent use, our clean room value is second to none. We sell our

Containing Bloodstream Infections

Pharmacy compounding is the process of combining drug ingredients to prepare medications that are not commercially available or to alter commercially available medications to meet specific patient needs such as dye-free or liquid formulations. Pharmacists traditionally have prepared medications to fulfill individual prescription requests or manipulated reasonable quantities of human drugs on receipt of a

Containing Bloodstream Infections Read More »

Pharmacy compounding is the process of combining drug ingredients to prepare medications that are not commercially available or to alter commercially available medications to meet specific patient needs such as dye-free or liquid formulations. Pharmacists traditionally have prepared medications to fulfill individual prescription requests or manipulated reasonable quantities of human drugs on receipt of a