Dust collection with limited floor space
Q: What are the dust collection options for solid dose manufacturing facilities with limited floor space?
A: David Steil, Camfil Air Pollution Control, says:
Effectively controlling the dusts generated in solid dose processing is essential for employee safety, product quality, and regulatory compliance. Standard dust collection systems don't meet the requirements of pharmaceutical manufacturers, who need a system that has a small footprint but still provides integrated, high-efficiency particulate air (HEPA) filtration; bag in/bag out (BIBO) filter changing; and an option for integrated controls and fan.
Tablet tooling steel quality, part 2 of a series
Q: How do I determine what type of steel I should use for my tablet press tooling?
A: Greg Beilsmith, Natoli Engineering, says:
In my previous article, I discussed how steel quality affects tablet compression tooling. A number of factors determine steel quality, including its cleanliness, the homogeneity of its microstructure, its grain size, and the size and distribution of its carbides. With a better understanding of steel quality and steel types, tablet manufacturers can compare steel from various tooling vendors to make an informed decision about the tooling they purchase.
The evolution of coating technology
John Murphy, Thomas Engineering
Pan coating is one of the oldest pharmaceutical solid oral dosage manufacturing processes. The process was created for adding a sugar coating to compressed tablets primarily to mask the tablets' unpleasant taste. An operator placed uncoated tablets into a solid, rotating pan and then ladled, dosed, or sprayed a sugar-based solution over them. The process could also include a sealing coat and/or subcoats and a wax topcoat to give the tablets a shiny finish.
Pan coating was considered an "art," because the quality of the coating depended largely on the skill of the operator. Inconsistent coating uniformity, long drying times between coats, and the long overall process time (24 to 48 hours or longer) were the main problems associated with solid pan coating. Subsequent developments such as the Pellegrini pan and the Glatt immersion sword helped to reduce processing times, but the most significant advancement in tablet coating equipment was the development of the perforated coating pan (or drum) by Eli Lilly, which Thomas Engineering commercialized in the 1960s.
As the perforated drum rotates around a horizontal axis, an inlet air-handling unit delivers conditioned, heated air into the coater and spray guns spray coating solution onto the tablets. The air is drawn through the tablet bed, drying the coated tablets, and exhausts via a sealed plenum on the outside of the drum. The perforated drum allows the coater to use more drying air, which greatly reduces drying time compared to a solid-pan coater.
For more information on this topic, you can read the article "Back Page: The evolution of coating technology," by John Murphy, Thomas Engineering. You can also find articles listed under "Tablet coating" in Tablets & Capsules' Article Archive.
Versatility and sensitivity of fiber-optic dissolution testing
Regarding the Solid Dose Digest's January 28 article, "Ask an Expert" on fiber-optic dissolution testing, one reader wrote us to point out several instances where fiber-optic testing may not be the best choice.
"In terms of versatility," he stated, "if you have a two-component product or a significant placebo effect, the fiber-optic method becomes unreliable. Reliance on curve resolution algorithms or derivative spectroscopy can introduce error and inaccuracy. High-performance liquid chromatography (HPLC) analysis can solve this problem."
The reader also mentioned that sensitivity "depends on the extinction coefficient of the substance being measured. If the substance has no UV, no sensitivity exists. Alternative methods such as fluorescence detection, refractive index detection for sugar-based drugs, and eventually, mass spectrometry-linked techniques provide greater sensitivity than fiber optics can achieve."
In a response to the reader's comments, the authors noted that the article was a comparison "between a conventional UV spectrophotometer analysis and a fiber-optic analysis" and that it was not meant to be a comparison "between liquid chromatography-mass spectrometry (LC/MS) or HPLC and fiber optics." As such, the information presented in the article was "correct for the specified analysis."
Do you have a comment or question about something you've read in the Solid Dose Digest? We'd love to hear from you. Email us at email@example.com.
FDA issues draft Guidance on content, format of marketing status notifications under Section 506I of the FFDCA.
To find more information about equipment suppliers at the Tablets & Capsules website, click here.
To find more events and continuing education opportunities at the Tablets & Capsules website, click here.
click below for more info
Capsule Filling Equipment
Manufacturing & Packaging
Nilfisk Industrial Vacuums
Metal Detectors/X-Ray Detectors
Mixers & Blenders
Nilfisk Industrial Vacuums
Kikusui USA Inc.
Nilfisk Industrial Vacuums
T&C Solid Dosage Sourcebook
Send your feedback or questions to Peggy Wright at firstname.lastname@example.org.
Copyright 2018, CSC Publishing Inc. All rights reserved.