August 3, 2021: Pharmaceutical Interview Questions and Answers

#WhatIsPrinting #OperatingPrinciplesPrintingEquipment #EquipmentClassificationPrinting #WhatIsDrilling

1. What is Printing?

The marking of a capsule or tablet surface for the purpose of product identification.

Printing may be accomplished by either the application of a contrasting colored polymer (ink) onto the surface of a capsule or tablet, or by the use of laser etching. The method of application, provided the ink formulation is not altered, is of no consequence to the physical-chemical properties of the product.

2. What is Drilling?

The drilling or ablating of a hole or holes through the polymeric film coating shell on the surfaces of a solid oral dosage form using a laser.

The polymeric film shell is not soluble in vivo. The hole or holes allow for the modified release of the drug from the core of the dosage form.

3. What are the Operating Principles of different equipment for Printing and Drilling?

Types of Printing/ DrillingDetails of Principles
Ink-Based PrintingThe application of contrasting colored polymer (ink) onto the surface of a tablet or capsule.
Laser EtchingThe application of identifying markings onto the surface of a tablet or capsule using laser-based technology.
DrillingA drilling system typically is a custom built unit consisting of a material handling system to orient and hold the solid dosage form, a laser (or lasers), and optics (lenses, mirrors, deflectors, etc.) to ablate the hole or holes, and controls. The drilling unit may include debris extraction and inspection systems as well. The sorting, orienting, and holding equipment commonly is provided by dosage form printing equipment manufacturers, and is considered ancillary in this use.

4. Equipment Classifications used for Printing and Drilling.

Equipment typeSub classification descriptionSub classification
Ink-Based PrintingInk-based printing subclasses primarily are distinguished by the method by which the marking is applied to a capsule or tablet surface.• Offset • Ink Jet
Laser Etching (Printing)Although laser etching systems may differ from one another, no laser etching subclasses have been identified.No sub class
DrillingThe method of producing the laser pulse that ablates the hole(s) is of no consequence to the physical-chemical properties of the product. Therefore, no dosage form drilling equipment subclasses have been identified.No sub class

Source: fda.gov

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