• gmp-verlag.de
  • GMP Compliance Adviser Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.


2. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.


3. GDP Audit Questionnaire
More than 700 questions with reference to regulations.


4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.


5. Data Integrity in the EU
Requirements for Quality Management Systems.


>>> More Downloads
GMP Compliance Adviser

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

Award
Image
The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

>>> ORDER NOW

GMP LOGFILE Features

2017-11-22

LOGFILE No. 44/2017 – Intermediate Bulk Container Systems

Intermediate Bulk Container Systems

An excerpt from the GMP Series PDF Download Technical Solutions for Personal Protection in Solid Drug Manufacturing

5 minutes reading time

by Richard Denk

 

Containers are classic systems for the internal transport and storage of intermediate and final products. Container systems have been used successfully for a long time in the area of containment. A distinction is made between split-valve and split-cone container systems.

Washing in place is only possible to a limited extent in the case of container systems. The level of automation is also an advantage when container systems are used. Container systems can be transported using AGVs (automatic guided vehicles) and automatically discharged, filled and cleaned.

Image

Figure 1 Cone system at the container outlet

Container with split-cone for discharging

In the container outlet, there is a closure cone which is paired with a flexible counter-cone at the discharging station. The container is emptied when the cone is raised (see Figure 1).

Image

Figure 2 Containment installation with a split-cone system in pharmaceutical formulation

The cone discharges the product and also functions as a containment system. By automatically adjusting the stroke of the cone, a predefined volume can be discharged from the container. The cone can be used as a dosing system. The discharging station is then placed on weighing cells (loss in weight), or weighing takes place during the next process step (gain in weight). The different height settings of the cone make it easier to discharge different substances. Partial discharging of the container is possible.

Another advantage is that the large outlet cross-section facilitates the discharge of poor-flowing products.

Sealed cone systems are also available for discharging big bags (see Figure 3). The benefit of this system is that the big bag is used as a single-use system. This means that time-consuming cleaning of the container is not necessary. The purchase price is lower than a similar container-based system. Another advantage of a flexible container is that it is better suited to poor-flowing products than a stiff container.

Image

Figure 3 Cone discharging system with big bags

Containment transfer unit at the container inlet for filling

A special containment lid is attached to the container inlet. The securely closed lid is removed from the container inlet by the filling head. The container lid is secured in the receptacle of the filling head in such a way that the filling head and container lid are largely free of residual product when filling has been completed. The filling head is located above the container filling station and is docked onto the container inlet using a lifting device (see Figure 4).

Image
Figure 4 Container filling system

Containment in mechanical systems such as the split-cone system or the containment transfer unit depends largely on engineering precision during manufacture and regular maintenance. Visible elimination of dust is only possible to a limited extent when this system is used. An OEL value of 10-100 µg/m3 can be achieved.

 

Author:

Richard Denk
SKAN AG, Allschwil, Switzerland

 

Image

Here’s an overview of what else you’ll discover in this GMP Series PDF Download:

  • Containment grades of products
  • Containment systems
  • Laminar flow, glove box systems
  • Single-use technology
  • Sampling during in-process control
  • Containment facility planning
  • Containment on equipment

Get started now! Order your copy of Technical Solutions for Personal Protection in Solid Drug Manufacturing

Comments
No comment has yet been written about this news.
 
 
Literature recommendation
Technical Solutions for Personnel Protection in Solid Drug Manufacturing
Applying the Principles of Hygienic Design to Solid Dosage Forms
GMP Compliance Adviser
Single User Licence (monthly subscription)