Download in electronic PDF format for $35



Search the Complete Journal Archives

Accuracy Considerations in Sterile Compounding

Author(s):  Akers Michael J

Issue:  Mar/Apr 2017 - Volume 21, Number 2
View All Articles in Issue

Abstract:  Published information about the accuracy of filling and closing operations of sterile products is limited and guidelines on the topic are very general. This article highlights the basic principles in sterile-product filling of syringes and vials. Also covered in this article are descriptions of some of the available devices for filling containers, a brief discussion of the advances in vial and syringe filling, a discussion on the advantages and disadvantages of sterile product filling methods, and a discussion on possible problems encountered during filling operations. Because of the extremely high costs of some new drugs, especially biopharmaceuticals, compounding pharmacies may prefer to fill small batches to reduce the risk of unacceptable monetary losses in the event of a manufacturing deviation that results in batch rejection.

Related Keywords: Michael J. Akers, PhD, compounded sterile products, compounded sterile preparations, sterile compounding, drug filling accuracy, sterile-product filling, syringes, vials, sterility assurance, gravity filling, piston filling, rotary pump filling, auger screw filling, vibrator filling, peristaltic filling, volumetric filling, liquid filling, time-pressure dosing, net weight filling, pre-filled syringe filling, excess volume recommendations, injectable solutions, United States Pharmacopeia Chapter <1>, USP, suspensions, dispersed system filling, checkweighing, integrated filling lines, compact filling lines, barrier isolators, rapid access barrier systems, closed vial filling, blow fill seal, plastic containers, glass containers, small batches

Related Categories: PACKAGING, PARENTERALS, STERILE PREPARATIONS, QUALITY CONTROL, DOSAGE FORMS/DRUG CARRIERS

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Accuracy Considerations in Sterile Compounding Akers Michael J Mar/Apr 2017 133-142 Buy
The Basics of Compounding: Compounding Powder-Filled Capsules Allen Loyd V Jr May/Jun 1999 209 Buy
Basics of Sterile Compounding: Sterile Product Packaging and Delivery Systems Akers Michael J Nov/Dec 2015 491-500 Buy
Basics of Sterile Compounding: Personnel Requirements for Sterile Compounding Akers Michael J Jul/Aug 2016 307-314 Buy
Quality Assurance for Sterile Products Kastango Eric S, Douglass Kate Jul/Aug 2001 246 Buy
Technology Spotlight: Liquid-Filling Machines Braverman Bob, Northcutt Kyle Nov/Dec 2002 439-440 Buy
Choosing a Vial Processing Line for Aseptic Compounding: Part 1 Noorian Shaun, Vahedi Navid Jul/Aug 2016 283-292 Buy
Microbiologic Testing for 503A Sterile-Compounding Pharmacies Mixon William, Roth Abby May/Jun 2017 193-203 Buy
Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists Rahe Hank Mar/Apr 2004 89 Buy
Basics of Sterile Compounding: Manipulating Peptides and Proteins Akers Michael J May/Jun 2017 223-228 Buy