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Pharmaceutical Industry News

Aseptic Enclosures – Pharmaceutical Industry News

counterfeit drugs

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

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

effective compounding strategy

Developing an effective compounding strategy

Developing an effective 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 with

Developing an effective compounding strategy Read More »

Developing an effective 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 with

risk of exposure to hazardous drugs

Risk of Exposure to Hazardous 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

Risk of Exposure to Hazardous 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

Exposure to Hazardous Materials

Exposure to Hazardous Materials during Shipping and Receiving

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

sterile compounding

Sterile Compounding USP 797 Solutions

  Sterile compounding is an essential element of patient care. Hospitals and clinics need to evaluate the best way to optimize care and meet regulatory and safety requirements while managing the costs of these important medicines. Our team of experts can help you evaluate external sources and the opportunity and requirements of insourcing this critical

Sterile Compounding USP 797 Solutions Read More »

  Sterile compounding is an essential element of patient care. Hospitals and clinics need to evaluate the best way to optimize care and meet regulatory and safety requirements while managing the costs of these important medicines. Our team of experts can help you evaluate external sources and the opportunity and requirements of insourcing this critical

Regulation for Compounding Aseptic Isolators

Prominently featured in the pharmaceutical manufacturing industry, a barrier isolator creates an aseptic environment for compounding parenteral (injectable), ophthalmic, and inhaled medications.  Due to the significant risk posed by microbiological contamination, the critical area where the compounding takes place requires protection beyond that of a typical laboratory glovebox. Since the first publication of USP’s General

Regulation for Compounding Aseptic Isolators Read More »

Prominently featured in the pharmaceutical manufacturing industry, a barrier isolator creates an aseptic environment for compounding parenteral (injectable), ophthalmic, and inhaled medications.  Due to the significant risk posed by microbiological contamination, the critical area where the compounding takes place requires protection beyond that of a typical laboratory glovebox. Since the first publication of USP’s General

503 b compounding pharmacy

Revised 503 b compounding pharmacy guidance

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

Basic Cleanroom Protocol

Basic Cleanroom Protocol

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

USP 797 & 800 Compliant Design Services

The Aseptic Enclosures pharmacy and cleanroom design and development team understands that a highly functional pharmacy begins with a soundly planned design. Our design team with combined years of experience and sophisticated design software with a collaborative approach is the perfect solution to ensure that your project will meet the required ISO or USP specifications.

USP 797 & 800 Compliant Design Services Read More »

The Aseptic Enclosures pharmacy and cleanroom design and development team understands that a highly functional pharmacy begins with a soundly planned design. Our design team with combined years of experience and sophisticated design software with a collaborative approach is the perfect solution to ensure that your project will meet the required ISO or USP specifications.

What Are Universal Precautions?

Working in the healthcare industry exposes individuals to diseases and infections that can be transmitted from one person to another. Universal Precautions were guidelines developed regarding infection control that were designed to protect healthcare workers from diseases that are spread through blood and various body fluids. These were applied to the workplace when workers were

What Are Universal Precautions? Read More »

Working in the healthcare industry exposes individuals to diseases and infections that can be transmitted from one person to another. Universal Precautions were guidelines developed regarding infection control that were designed to protect healthcare workers from diseases that are spread through blood and various body fluids. These were applied to the workplace when workers were