GMP Cleanrooms: Annex 1 & CCS Compliance Guide

cGMP Support & Annex 1 Compliance

At ABN Cleanroom Technology, we understand that GMP cleanrooms are essential for industries producing sterile medicinal products. Any application involving the production, filling, compounding, or packaging of sterile medicines must comply with GMP standards. Our expertise extends to critical cleanroom applications such as:

Cell and gene therapy

Medical device manufacturing

Pharmaceutical manufacturing

Radiopharmaceutical manufacturing

We are experienced in European regulations outlined in EudraLex, Volume 4 – Good Manufacturing Practice (GMP). Specifically, Annex 1 provides crucial guidelines for the design, control, and operation of sterile product facilities. With the recent Annex 1 update effective August 25, 2023, companies are required to use a risk-based approach to control contamination at every stage. To meet these stringent requirements, we offer expert guidance on implementing a Contamination Control Strategy (CCS).

The Superior Path to Compliance: Configure-to-Order Plus (CTO+)

The traditional approach relies on custom Engineer-to-Order (ETO) projects, introducing design risk and validation complexity. We move beyond this risk by leading with a Configure-to-Order (CTO) solution. By building your modular cleanroom from our pre-engineered, validated ADAPTUS components, we guarantee reliability and control before installation begins.

What Are GMP standards relevant to cleanroom solutions?

Good Manufacturing Practices (GMP) are the cornerstone of quality control. These practices ensure cleanroom environments remain controlled to prevent microbiological, particulate, and pyrogen contamination during production. We reduce the complexities of GMP standards by implementing proven, productized processes. GMP standards ensure products are consistently high-quality and compliant. We specialize in cleanroom qualification and validation (CQV), which follow four essential stages:

Design Qualification (DQ)

Verification that the GMP cleanroom design meets defined regulatory and process requirements. Configured from pre-validated ADAPTUS components, supporting initial compliance from the start.

Installation Qualification (IQ)

Verification that the cleanroom is installed according to the approved design and specifications. Standardized Configure-to-Order components simplify and accelerate on-site verification.

Operational Qualification (OQ)

Confirmation that cleanroom systems operate within defined parameters. Use of pre-tested systems ensures consistent performance to specification.

Performance/Process Qualification (PQ)

Verification that the cleanroom operates consistently in a controlled and repeatable state. Proven Configure-to-Order architecture supports reliable, repeatable performance across deployments.

Contamination Control Strategy (CCS) & GAP Analysis

A CCS is a comprehensive plan that consolidates all controls designed to prevent contamination. We assist our clients in developing a robust CCS, supported by risk assessments and scientific evidence. The CTO Advantage for CCS: our configured solutions inherently reduce contamination risk by designing out the typical failure points of custom builds. For example, our system incorporates features like:

Non-intrusive maintenance: Our designs allow critical servicing to be carried out from non-classified areas. This reduces the need for technicians to enter the cleanroom and lowers contamination risk during maintenance.

We conduct a gap analysis to review your current practices and work with your team to develop a clear CCS. This helps reduce contamination risk across all stages of production.

Our services

At ABN Cleanroom Technology, we provide cleanroom services that meet the highest standards. As a turnkey provider, we manage the entire process from design to installation and long-term support.

Moreover, our services include cGMP compliance, environmental monitoring, and full validation. Whether you’re launching a new facility or upgrading an existing one, we deliver tailored solutions that align with your goals.

cGMP Support

Monitoring services

Commissioning, Qualifications & Validation

Cleanroom facility management

Cleanroom renovation & upgrades

Let's talk cleanrooms

Whether you’re looking for expert advice, a quick answer, or a detailed discussion, we’re here to help. Choose the option that works best for you: call us directly, send us an email, or book a 30-minute meeting at your convenience.