PubMed · 7928585
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J Gushee. 1994-07-15. When does compounding become manufacturing?. https://pubmed.ncbi.nlm.nih.gov/7928585/
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Roller compaction (RC) is an important dry granulation technique. Since pilot and commercial scale roller compactors, which operate continuously on a large scale, usually require kilograms of material per run, formulation and process development directly on such roller compactors is not practical. In contrast, a compaction simulator (CS) can produce ribblets, also known as "slugs", using only a few grams of material with sinusoidal displacement profile replicating the motion of a specific point on the roll surface. Thus, it is possible to develop RC formulation and process in laboratory using a CS-based material-sparing approach. However, because of the inherently different configurations for applying pressure between die compression and roll compression, translating uniaxial pressure from CS experiments to roll pressure during RC is often unreliable, leading to significant uncertainties in the critical quality attributes of ribbons, such as ribbon solid fraction (or porosity) and mechanical strength. The objective of this study was to identify a correction factor (Kp = uniaxial die compression pressure/roll pressure), by correlating the compressibility profiles from CS and a roller compactor of interest, to enable more reliable process translation from CS to roller compactor. In this study, a Kp value of 0.5 was determined for Alexanderwerk WP120 and validated for Gerteis Mini-Pactor and Bepex Pharmapactor. This value may serve as a starting point for translating the optimal compaction pressure identified based on CS investigation to common roller compactors, requiring only minor adjustments to attain optimal RC process parameters (i.e., roll force and roll gap) for a chosen roller compactor.
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The results of a survey of hospital pharmacy and home infusion facility activities for quality assurance in the preparation of sterile drug products are reported, and the hospital results are compared with those of a 1991 ASHP survey. A questionnaire was mailed in May and June 1995 to 778 hospital pharmacy directors and 203 home infusion pharmacy directors. Usable questionnaires were returned by 547 hospitals and 111 home infusion facilities, for an overall response rate of 67%. The percentages of hospitals with pharmacists involved in extemporaneous (70%) and batch (28%) preparation of sterile drug products have decreased since 1991, while the percentage with technicians who are not limited as to the types of sterile products they may prepare has increased. Some 16% of all sterile products compounded in hospitals were prepared by nonpharmacy personnel. Few respondents contracted with outside sources for compounding of sterile products. A need for educational programs on aseptic technique was identified by 83% of hospitals, and 84% of home infusion facilities indicated a need for education on environmental monitoring. Three fourths of respondents used the ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products in developing their policies and procedures. Significant improvements in orientation and training techniques have occurred since 1991. Use of a laminar-airflow hood in a limited-access room has increased. The aspects of sterile product compounding most often modified since 1991 were, for hospitals, personnel training and evaluation (74%), facilities and equipment (48%), and garb policies (36%); for home infusion facilities, personnel training and evaluation (76%), facilities and equipment and garb policies (both 69%), and end-product testing and evaluation (66%). There have been advances in quality assurance procedures related to pharmacy-prepared sterile products, but opportunities for improvement remain.