Let’s discuss what that means, and what GMP workflow requirements include below.
What Is a GMP Cleanroom?
A GMP cleanroom is one that complies with Good Manufacturing Practice (GMP) standards. GMP is a quality management system used predominantly by medical and pharmaceutical manufacturers to ensure a controlled cleanroom environment for operations.
The main goal of GMP standards is to minimize the risks of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices. Any application that involves producing, filling, compounding, or packaging sterile medicinal products must comply with GMP standards in order to ensure a high level of product safety and consistency. To achieve this level of control, safety, and repeatability, GMP standards address a wide range of cleanroom issues, including:
- Equipment verification
- Personnel qualification
- Process validation
- Sanitation and cleanliness
- Record keeping and documentation
For this article, we’re focusing on just one of the GMP cleanroom issues listed above: workflow.
What Are GMP Cleanroom Requirements for Workflow?
In medical and pharmaceutical cleanrooms, operations must be efficient, but also highly controlled. GMP standards can help you design and operate a cleanroom that meets both of those needs, as they outline guidelines for safe and effective workflow.
To start, there are two main categories of cleanroom workflow to understand: material flow and personnel flow.
Material Flow for GMP Cleanrooms
Material flow is the method and route in which various materials move throughout a cleanroom. From product testing and development all the way to product packaging, GMP standards require that there needs to be a plan in place for materials to be moved safely and efficiently. This helps to protect sensitive materials from outside contaminants and to protect operators while handling potentially hazardous substances.
When designing a route for materials to move throughout your cleanroom, make sure you consider the following:
- Where and how will materials be processed? What level of environmental control does this require?
- What are the guidelines for cleanroom operators when handling materials?
- How will materials be transported? What equipment may you need?
- How and where will materials be tested? What level of environmental control does this require?
- Does your cleanroom require any material pass-through chambers to ensure the safe handling and transportation of materials?
- Where and how will materials be stored when not in use?
Personnel Flow for GMP Cleanrooms
Personnel flow is the method and route in which cleanroom operators move through a cleanroom and perform tasks. If you have previous cleanroom experience, you may already know that one of the biggest threats to medical cleanrooms is contaminants from personnel — but a comprehensive, well-designed personnel flow plan can help reduce this risk. Personnel flow takes into account the introduction of contaminants from personnel, the prevention of cross-contamination, the protection of personnel from potentially harmful substances, and the efficiency of personnel.
When designing a route for personnel to move throughout your cleanroom, make sure you consider the following:
- Which cleanroom tasks are the most sensitive, and which ones are the least sensitive? Based on that, in what order should cleanroom operators’ tasks be completed?
- Where and how will operators put their gowns and garments on/off?
- What type of non-shedding fabrics will be used for operator gowns and garments? How will these gowns and garments be stored?
- How long will operator gowns and garments be used before disinfection or disposal?
- How will operators be trained?
- How often should operators wash their hands?
- When and how will cleanroom surfaces be sanitized?
- How do all of these considerations fit within a single, streamlined route through your cleanroom?
Overall, the main priority in designing a safe and effective personnel flow is having one route in the cleanroom and one route out of it. Here’s an example:
A cleanroom operator stages materials in a pass-through chamber. Then, they move to a gowning room to outfit themselves in appropriate gowns and garbs and enter the cleanroom. From there, they retrieve the materials at the other side of the pass-through chamber within the cleanroom. They perform their task at the necessary cleanroom station, then place the materials in a safe, controlled storage container. They then exit the cleanroom through the gowning room and remove their gowns and garbs into a designated bin.
Why Are GMP Cleanroom Workflow Requirements Important?
Mainly, GMP cleanroom workflow requirements are important in protecting the safety, efficacy, and repeatability of products. They also go to great lengths to protect the safety of those handling the products, which could be harmful to human health.
However, another important factor in GMP cleanroom workflow is designing a logical route that improves efficiency and productivity. This can help cleanroom facilities reduce downtime and labor costs, while maximizing cost-effectiveness and profitability.
How to Meet GMP Cleanroom Requirements for Workflow
So, how can you get your cleanroom to meet GMP workflow requirements? Depending on the scope, industry, and details of your cleanroom, the process can greatly vary. However, there are two main steps that remain the same.
- Step 1 — Work With a GMP Cleanroom Manufacturer. Do your research and find a reputable cleanroom manufacturer that has experience designing and installing GMP cleanrooms. They’ll help you create a design that both meets the needs of your facility and is compliant with applicable regulations.
- Step 2 — Obtain Necessary GMP Qualification and Validation. The GMP qualification and validation process has four stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance/Process Qualification (PQ). All of these stages require you to meet different criteria that ensure your cleanroom is GMP compliant and meets workflow requirements.
Get Safe & Effective GMP Cleanroom Solutions From Angstrom Technology
If you plan to install a GMP cleanroom, you need to ensure it meets established workflow requirements. This process can get a little complicated, so if you need help, contact our cleanroom experts at Angstrom Technology. We have extensive experience building GMP cleanrooms, and we’re happy to help you with yours.