Continuous Vs. Batch Manufacturing

Author:

Hassan Mostafa Mohamed, Chairman & Chief Executive Officer at ReyadaPro

The pharmaceutical manufacturing industry is different from other industries in that it is concerned with human health and follows a highly sensitive and critical operating scenario, aiming to produce pharmaceutical drugs for public treatment. The pharmaceutical manufacturing industry has until now followed a batch processing scenario to ensure that each batch was produced efficiently and effectively, conforming to its pre-planned specifications and in compliance with cGMP and regulatory requirements. A particular quantity of a medication or other substance that is produced in accordance with a single production order and is produced during the same manufacturing cycle is referred to as "batch processing" in regulations like the FDA's Code of Federal Regulations (21 CFR) 210.31. To put it another way, it entails the step-by-step assembling of various product components to produce the finished manufactured product.

Introduction

In batch processing, a subsequent batch can be processed only after the current batch has been completed. Continuous pharmaceutical manufacturing [CM] has become increasingly popular in recent years, but the transition from batch to continuous manufacturing is still under evaluation.

Continuous manufacturing [CM] is a production scenario that uses the continuous supply of raw materials directly within the manufacturing process at the same facility without stopping and/or shutting down until completion.

In this article, we shed light on a new recent scenario for producing pharmaceutical products and the one currently in place, discuss the challenges and pros and cons of each, and make comments on them.

Continuous Manufacturing vs. Batch Processing

Pharma manufacturing industries are complicated and depend on several factors, such as capital expenditures ("CAPEX") that include infrastructure, supplied resources, buildings, equipment, machines, etc., in addition to giving a great deal of attention to operation expenditures ("OPEX") to assure the effect of planning, doing the proper feasibility studies, and analyzing the relevant market trends, including competent personnel contributions as decision makers to ensure successful production operations.

Pharma manufacturing needs to include consumer demands, industry competitions, manufacturing legal requirements, and the correct implementation of a quality management system (QMS) to ensure the smooth running of manufacturing processes and relevant integrated processes, aiming to get the product as per the approved specifications, fit for its intended use, and attain the best possible return on investment (ROI) for the sake of the stakeholders.

As per recent market trends, the pharmaceutical industry loses about $50 billion due to the shortcomings of batch processing as a result of time constraints, delivery issues, damage, or the cost of a review.

Senior management should pay close attention to the analysis of the factors and attributes controlling the manufacturing processes before deciding which manufacturing method is reliable and appropriate for their manufacturing methodology, taking into account applying and adhering to all relevant pharma legislation and regulation and coming in at the bottom of the list.

Continuous manufacturing and batch processing are two sides of the same coin. Both are used in different manufacturing industries, "especially pharmaceutical manufacturing," provided that they consider the relevant regulations and requirements aiming to produce pharmaceutical drugs as per the approved specifications, in compliance with cGMP regulations, and fit for their intended use.

Manufacturers have been producing pharmaceutical products using batch processing for many years. A batch is defined in the FDA’s Code of Federal Regulations (21 CFR) 210.3 as a certain amount of a drug or other material that is intended to have a uniform character and quality within defined limits and is manufactured according to a single production order during the same manufacturing cycle.

Multiple components of a drug are mixed in a single step during batch processing. Each stage of the creative process requires a break from batch processing. It takes multiple stages [in terms of time, money, and labour] as the materials go from step to step to process the current batch before the next batch can be processed.

The European Medicines Agency's EMA ICH Q7 defines a batch in batch processing as a homogeneous material that falls within specific parameters. According to EMA ICH Q7, a batch can correspond to a specific percentage of the production in the event of continuous manufacturing. The batch size can be defined both as a fixed quantity and as a fixed time interval.

Read more: https://www.pharmafocusamerica.com/manufacturing/continuous-batch-m00anufacturing