Hello good people of the world! Continuing the series on oral solid dosage forms, today we’re going to talk about unit operations typical in a oral solid dose manufacturing process.
Typical OSD processes may include some combination of weighing/dispensing, material transfer, blending, granulation, drying, milling/sieving, compression, encapsulation, and coating. Some considerations around each step may include:
Weighing/Dispensing: includes sampling for quality purposes. Materials to be sampled typically include: APIs, excipients, primary and secondary packaging, cleaning agents. Sampling areas must be protected from contamination.
Material Transfer: material flows should be documented and reviewed, with the intention of minimizing any contamination.
Blending: materials are typically blended to ensure a uniform composition, prior to downstream process steps. Many methods exist, including: tumble blending, bin blending, and agitator mixers.
Granulation: granulation is the process of combining particles into a granule. Many methods of granulation exist: wet massing/extrusion, high shear, spray, speronization, and hot melt extrusion, for example.
Drying: the purpose of the drying step is to remove any excess moisture from the drug product. Drying methods include: tray , fluidized bed, and spray drying.
Milling/Sieving: the purpose of this process step is to reduce granule size to conform to specification. Some methods include: impact/hammer mills, conical mills, and oscillating horizontal screens.
Compression: compression is used to create tablets.
Encapsulation: encapsulation is used to create capsules.
Coating: coating is used to apply a coat to tablets
In the next post we’ll cover supporting equipment and quality systems. What process steps do you use in your OSD process? Comment below!
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Hello good people of the world! Another short post today, this one on the revision to EudraLex Volume 4 (GMPs) dated 13 August 2014. The revision is here. A short revision, the changes include updates to Chapter 3 (Premises and Equipment) and Chapter 5 (Production) around prevention of cross-contamination and qualification of suppliers.
Of note is the increased guidance around the use of quality risk management principles.
The revision will come into affect in March 2015.
What do you think of these changes? How will you adjust your quality program, if at all?
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Hello, good people of the world! How to define DQ? One way: DQ = documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose Continue reading Design Qualification (DQ)→
Hello, good people of the world! Recovery studies are studies to support surface swab processes. They typically involve “spiking” a “coupon” made from a particular material with a known amount of the contaminate you’re interested in, and then systematically quantifying the amount recovered via the swab process.
You’ll need to perform recovery studies for all product-contact materials you have in your manufacturing process. These typically include 316L stainless steel, PTFE, glass, etc.
Hello, good people of the world! If you know me, then you know I’m into “metrics” – ways to evaluate the health of a system or process quantitatively. We know finding and correctly interpreting the “right” metrics is not trivial, and looking at the “wrong” metrics can do more harm then good.