Parenteral Process Guide – Formulation by Merck

Parenteral Process Guide - Formulation

Single-use components, excipients, filters and validation services

Reduce risk and increase efficiency with a fully assembled ready-to-use system:

• Let us help you design a process to meet your specific needs.
• What are the risks you are facing?
• What are your set-up and system issues to consider?

 

Parenteral Process Guide - Formulation_1One-stop-shop to ensure component and process fit

Reduced risk of cross contamination and enhanced operator safety

Offering embedded in the Emprove® Program to facilitate regulatory compliance

Parenteral Process Guide - Formulation_2Increase efficiency by reducing process and changeover time

Flexible manufacturing through:
• Reduced and flexible footprint allowing more free capacity
• Dedicated product and service offering

Quick link to technical and quality related solution

See the overview video

 

 

Parenteral manufacturing process

Parenteral Process Guide - Formulation_3

Formulation

  • Selecting high quality excipients
  • Mixing of ingredients
  • Monitoring critical parameters

Filtration

  • Assure sterility of the
    drug product
  • Contamination-free and
    closed sampling
  • High recovery and low cost
    of goods

Filling

  • Improve manufacturing
    flexibility
  • Increase productivity
  • Meet evolving manufacturing
    needs

Key steps for formulation

Select excipients

  • Specifications and quality attributes designed for liquid formulations
  • Reduce risk and simplify processes
  • Reliable performance
  • Parenteral Process Guide - Formulation_select excipientsEnsure speed to market

 

Mixing

  • Parenteral Process Guide - Formulation_mixing

    Ensure mixing performance

  • Gain flexibility through various working volumes and movability
  • Choice for closed processing or open liners

Sterile sampling

  • Improve operator safety
  • Assure process sterility
  • Sample representativity
  • Ease of use

Choosing the right excipients for reliable performance and quality

Parenteral Process Guide - Formulation_Consideration 1
Delivering State of the API

 

Parenteral Process Guide - Formulation_Consideration 2
Ensuring Reliable Performance of the Final Drug Product

 

Parenteral Process Guide - Formulation_Consideration 3
Market Readiness

 

Parenteral Process Guide - Formulation_Consideration 4
Handling Powdered Raw Materials

 

You will read more on the Parenteral Process Guide to the themes Formulation, Filtration and Filling by Merck during the next days.

Until this see the full interactive brochure onParenteral Process Guide – Formulation, Filtration, Fillinghere

(click the picture to download the brochure)

Parenteral Process Guide - Formulation, Filtration, Filling

Source: Merck brochure “Parenteral Process Guide – Formulation, Filtration, Filling”


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