Process, challenges

Kocb s process also permits recovery of prebnitene, isodurene, and pentametbylbenzene by fractionation. In tbe case of isodurene, only 85% purity is acbieved wben tbe filtrate from tbe durene crystallization unit is redistilled durene is tbe principal impurity. Altbougb bexametbylbenzene can be synthesized via the trimethylation of the readily available pseudocumene, its high melting point (105.5°C) presents more of a processing challenge. 

Thames SF, Bautista MO, Yu H, Panjnani KG, Wang MD (1996) Proceedings 41st International SAMPE Symposium and Exhibition. Materials and process challenges aging systems, affordability, alternative applications, hook 2. SAMPE, Long Beach, pp 1191-1202... 

In this chapter, we discussed different approaches used for the design and fabrication of power SiC MOSFETs, including a review of the various structures (UMOS, DMOS, and LDMOS) and process challenges associated with each structure. 

Process challenging and characterization reports that contain a full description of the studies performed Development batch record Raw material test methods and specifications... 

Table II. Resid Processing Challenges and Catalyst Development...

PROCESS CHALLENGES DURING DRY GRANULATION OPTIMIZATION FOR LOW-DOSE PRODUCTS... 

TABLE 6.12 Process Challenges for Optimizing a Low-Dose Dry Granulation Process... 

Process Challenges Driver Method of Assessment Attribute... 

A fifth process challenge in the optimization of a dry granulation process is to achieve a granulation that is resistant to fluidization and sifting segregation forces. In general, process parameters that influence segregation potential are similar to those that influence variability in sieve cut potency. 

In summary, the process challenges that impacted quality considerations included 1, 4, 5, and 6, whereas 2, 3, 7, and 8 affected manufacturing considerations during drug product development for these low-dose products. 

The formulation and process challenges encountered in the development of low-dose drug products using dry granulation have been thoroughly discussed. In addition,... 

In the case where stability issues prevent the pursuit of the preferred formulation, then it becomes more important to optimize the dry granulation process to achieve an improved uniformity of drug as a function of particle size. For these cases, it is important to consider the impact of the optimized granulation on tableting performance. Although it is important to consider the commercial manufacturing efficiency, the process challenges that impact quality are of primary importance. 

Ontario, 12th-14th Oct.1999, p.48-51 NEW LOW PLATE OUT RIGID PVC LUBRICANT SYSTEM TO MEET THE PROCESSING CHALLENGES OF TODAY S HIGH-OUTPUT EXTRUSION PROCESS Decker R W Falter J A Henkel Corp. 

Volume 535— lll-V and IV-IV Materials and Processing Challenges for Highly Integrated... 

At the end of the product development phase and prior to process validation, a product review should be performed to ensure that the development is complete, and that the various processes for manufacture are capable of passing process validation. At this point, any gaps in the development process may be further studied and attended to, prior to performing process validation (e.g., logo printing process development), preferably at full scale. It is advisable to manufacture two or more process challenge batches to show that the product is acceptable at the upper and lower process ranges. This helps to ensure that validation will be successful. 

Acharya, P., Fogo, D., and McBride, C., Process challenges in rotary kiln-based incinerators in soil remediation projects, in Proceedings of the 1995 International Incineration Conference, Bellevue, WA, May, 1995, 637. 

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