Target Selection and Qualification: The Case of Blister-Filling and Packaging Systems - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Target Selection and Qualification: The Case of Blister-Filling and Packaging Systems
The authors propose an approach for qualification-target selection and show how it can be applied to blister-filling and packaging systems.

Pharmaceutical Technology
Volume 33, Issue 1, pp. 72-80

Other devices (e.g., the plastic-film-feeding device) and their corresponding functions (e.g., the plastic-film-feeding function) should follow GEP but do not require qualification.

In principle, qualifications are carried out after GEP are applied. But the stages from design qualification (DQ) to operational qualification (OQ) can be carried out in parallel with GEP according to a prior plan to avoid duplicate application or backtracking.

Direct factors are classified as dynamic factors (e.g., the plate temperature of the heating device) and static factors (e.g., the shape and size of the forming die). Dynamic factors are further classified as either being subject to process control or not. The overall classification of direct factors is as follows:

  • Class 1: Dynamic factors that affect quality
  • Class 1-A: Dynamic factors subject to process control
  • Class 1-B: Dynamic factors not subject to process control
  • Class 2: Static factors that affect quality.

Class 1-A factors can be changed when the system is in operation. They should be observed, recorded, and adjusted so that they stay within the predefined control range.

Class 1-B factors cannot be changed when the system is in operation. They should be set or adjusted in advance of operation.

Class 2 factors (e.g., material, configuration, and surface finish) are fixed when the system is constructed and, in principle, do not change afterward.

Devices used to measure and control the dynamic factors and computerized control devices must be calibrated and validated, respectively. Calibration and computerized-system validation should occur before the start of OQ, which is the third stage of qualification.

The following precautions are important for constructing medical manufacturing systems and should all adhere to GMP:

  • Protection against foreign substances
  • Ensuring the correct product is packaged
  • Protection against cross contamination.

These precautions relate chiefly to the working environment, working control, and maintenance checks. They can be taken independently of the systems. Therefore, the functions and devices related to the items above are not subject to qualification and should simply follow GEP.

Direct factors of blister-filling and packaging systems

Quality of blister products. Blister packages should protect their contents (e.g., tablets) to control their stability, dissolution, and disintegration. This article takes the protective function of blister packages as one element of the required quality for blister products.

Figure 1: The manufacturing process of a blister pocket. (All figures are courtesy of the authors and the Japan Society of Pharmaceutical Machinery and Engineering.)
The important elements of product protection are appropriate web thickness, which prevents vapor or oxygen-gas ingress, and proper sealing, which maintains airtight pockets (see Figure 1).

Criteria for screening the functions. The following criteria should be used to identify the devices and parts of blister-filling and packaging systems that are direct-impact factors:

  • Whether the given function affects web film thickness
  • Whether the given function affects the seal quality.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here