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Accuracy Considerations in Sterile Compounding

Author(s):  Akers Michael J

Issue:  Mar/Apr 2017 - Volume 21, Number 2
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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


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