Nursing Perspective to USP <800>

Developing standard operating procedures (SOPs) and ensuring ongoing adherence is integral to a successful hazardous drug (HD) safety program. Furthermore, it is required by USP <800>, as Section 8 states that organizations must develop SOPs to cover all aspects of HD handling.

Preventing Contamination In Compounding Facilities

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 back to as early as 1976.2 Despite attempts by the United States Pharmacopeia (USP) to make compounding safer, problems still occur.

Personnel Aseptic Practices Training

Personnel Aseptic Practices Training

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 complex as the cleanroom grades increase.

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan Tablets

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

How should we Keep Cleanrooms Clean

Controlling microbial ingress into the cleanroom is a critical concern for the entire cleaning and disinfection process. Components, personnel, carts, tanks, tools, cleaning supplies, and instruments that are transferred into the clean area should be clean and free of contamination. Gross contamination is easier to prevent than to correct.

Updated Guidance for Compounding Facilities 503B

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 Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility’s operations.

Happy New Year

The team at Aseptic Enclosures wishes you peace, joy and prosperity throughout the coming year.


Thank you for your continued support and partnership. We look forward to working with you in the years to come.


Schedule an on-site visit for an Aseptic Enclosures’ evaluation of your facility

 

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.

Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline

Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. (Editor’s note: On June 30, FDA issued new draft guidance pushing back the enforcement deadline for product identifiers to Nov. 27, 2018, though the compliance deadline remains Nov. 27, 2017.) Many drug makers have been preparing for this so-called “serialization” deadline for years by implementing new processes and systems in their internal operations, or by ensuring efficient transfer of serialization data from their contract manufacturing/packaging partners. However, some manufacturers — in particular, smaller or virtual firms — are now engaged in a mad scramble to meet all the requirements of the deadline.

Happy Independence Day!!!

Aseptic Enclosures team would like to wish our valued customers a happy 4th of July.