Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

628
Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
628
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

314
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
314
Precipitation Processes01:12

Precipitation Processes

5.8K
The experimental conditions in a gravimetric analysis should be optimized to maximize the particle size and purity of the obtained precipitate. Ideally, the concentration of the precipitating reagent should be low with effective stirring to maintain low relative supersaturation for the growth of large crystals. In homogeneous precipitation, the precipitant is slowly generated by a chemical reaction in the solution to avoid local reagent excesses. For example, urea decomposes gradually to...
5.8K
Isothermal Processes01:21

Isothermal Processes

4.9K
A thermodynamic process that occurs at constant temperature is called an isothermal process. Heat slowly flows into the system or out of the system to maintain thermal equilibrium. Processes involving phase changes like water evaporation into steam or freezing water into ice at a constant temperature are examples of Isothermal Processes.
An ideal gas can also undergo isothermal expansion or compression.
For example, consider 1 mole of an ideal gas inside an isolated cylinder at initial volume V...
4.9K
Work Done in an Adiabatic Process01:20

Work Done in an Adiabatic Process

4.2K
Consider the adiabatic compression of an ideal gas in the cylinder of an automobile diesel engine. The gasoline vapor is injected into the cylinder of an automobile engine when the piston is in its expanded position. The temperature, pressure, and volume of the resulting gas-air mixture are 20 °C, 1.00 x 105 N/m2, and 240 cm3 , respectively. The mixture is then compressed adiabatically to a volume of 40 cm3. Note that, in the actual operation of an automobile engine, the compression is not...
4.2K
Processes of Self-Presentation01:29

Processes of Self-Presentation

212
Effective self-presentation is a central component of social interaction and identity construction. It relies on the dynamic processes of defining the situation and engaging in self-disclosure. These mechanisms help individuals navigate social context expectations and manage how others perceive them, fostering mutual understanding and relationship development.Defining the SituationSocial situations are shaped by collectively understood frames—a set of widely understood rules or...
212

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Consent and assessing capacity in perioperative and intensive care.

BJA education·2026
Same author

Discrete element analysis of the effect of particle cohesion on die filling behaviour of pharmaceutical powders in a rotary tablet press.

International journal of pharmaceutics·2026
Same author

Exploring twin-screw feeding behaviour across different loss-in-weight feeders.

International journal of pharmaceutics·2026
Same author

The effect of material properties and process parameters on die filling using double-tip tooling: A PLS-model-based analysis.

International journal of pharmaceutics·2025
Same author

The effect of material properties and process parameters on die filling at varying throughputs: A PLS-model-based analysis.

International journal of pharmaceutics·2024
Same author

Semi-crystalline materials for pharmaceutical fused filament fabrication: Dissolution and porosity.

International journal of pharmaceutics·2024

Related Experiment Video

Updated: Jan 23, 2026

Measurement of Neurophysiological Signals of Ignoring and Attending Processes in Attention Control
09:37

Measurement of Neurophysiological Signals of Ignoring and Attending Processes in Attention Control

Published on: July 5, 2015

9.5K

PAT-based batch statistical process control of a manufacturing process for a pharmaceutical ointment.

N Bostijn1, W Dhondt2, C Vervaet3

  • 1Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|June 7, 2019
PubMed
Summary

A new process analytical technology (PAT) model uses batch statistical process control (BSPC) to monitor ointment manufacturing. This method enables early detection of process deviations, preventing batch failures and ensuring product quality.

Keywords:
Batch statistical process controlFocused beam reflectance measurement (FBRM)Multivariate data analysisPharmaceutical ointmentProcess analytical technologyRaman spectroscopyViscometer

More Related Videos

Manufacturing, Control, and Performance Evaluation of a Gecko-Inspired Soft Robot
07:40

Manufacturing, Control, and Performance Evaluation of a Gecko-Inspired Soft Robot

Published on: June 10, 2020

15.3K
Author Spotlight: Advancements in the Fabrication of Synthetic Vocal Fold Models for Phonetic and Robotic Applications
06:24

Author Spotlight: Advancements in the Fabrication of Synthetic Vocal Fold Models for Phonetic and Robotic Applications

Published on: January 5, 2024

1.3K

Related Experiment Videos

Last Updated: Jan 23, 2026

Measurement of Neurophysiological Signals of Ignoring and Attending Processes in Attention Control
09:37

Measurement of Neurophysiological Signals of Ignoring and Attending Processes in Attention Control

Published on: July 5, 2015

9.5K
Manufacturing, Control, and Performance Evaluation of a Gecko-Inspired Soft Robot
07:40

Manufacturing, Control, and Performance Evaluation of a Gecko-Inspired Soft Robot

Published on: June 10, 2020

15.3K
Author Spotlight: Advancements in the Fabrication of Synthetic Vocal Fold Models for Phonetic and Robotic Applications
06:24

Author Spotlight: Advancements in the Fabrication of Synthetic Vocal Fold Models for Phonetic and Robotic Applications

Published on: January 5, 2024

1.3K

Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Analytical Technology

Background:

  • Traditional pharmaceutical manufacturing relies on offline quality control, leading to delays and potential batch loss.
  • Implementing real-time monitoring is crucial for efficient and robust pharmaceutical production.

Purpose of the Study:

  • To develop and evaluate a Process Analytical Technology (PAT)-based Batch Statistical Process Control (BSPC) model for laboratory-scale pharmaceutical ointment manufacturing.
  • To assess the model's capability in detecting process and formulation deviations during real-time monitoring.

Main Methods:

  • A multivariate Batch Statistical Process Control (BSPC) model was developed using Partial Least Squares (PLS) analysis.
  • In-line data from viscosity, product temperature, particle size distribution (PSD), and active pharmaceutical ingredient (API) concentration were collected using viscometers, focused beam reflectance measurement (FBRM), and Raman spectroscopy.
  • Two test batches with induced disturbances were monitored to validate the model's performance.

Main Results:

  • The BSPC model successfully acquired the characteristic trajectory of the ointment manufacturing process under normal conditions.
  • Induced process disturbances (elevated temperature) and formulation changes (staggered API addition) were accurately detected by the in-line PAT tools and the BSPC model.
  • Real-time monitoring allowed for early fault detection and facilitated timely process adjustments.

Conclusions:

  • The PAT-based BSPC model effectively monitors pharmaceutical ointment manufacturing, enabling early fault detection and real-time process adjustments.
  • This approach prevents batch loss or reprocessing, demonstrating the feasibility of in-line quality attribute measurement during ointment production.