Certainty for Your Most Complex Projects
A GMP-compliant manufacturing or ISO 17025-accredited testing facility is the cornerstone of product quality and market competitiveness. The governing standards—including the FDA's Code of Federal Regulations and the ISO 14644 series for cleanrooms—form an integrated system of requirements. Our approach holistically addresses these standards to deliver a fully validated, audit-ready operational environment from day one.
Why Partner with Connected?
We translate the principles of regulations like FDA 21 CFR Part 211 into tangible facility layouts, material specifications, and engineering controls that ensure compliance. Our project delivery includes a comprehensive turnover package with all qualification protocols (IQ/OQ/PQ) and reports, ensuring a smooth validation process.
Proof in Practice: Our Specialist Projects
We have a proven track record of delivering highly technical, GMP-compliant, and specialized industrial facilities. We leverage our global expertise to inform every US project.
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Glenn Chellberg
Director
Marlon Lock
Director
Terry Coulter
Pre-Construction
Engineering for Compliance: Critical FAQs for High-Stakes Facility Design in the US
ISO 14644-1 provides the technical specification for air cleanliness based on particle counts (e.g., ISO 5 is equivalent to the old Class 100). The FDA and USP provide the regulatory application, dictating which ISO class is required for a given process based on risk. For example, USP <797> requires critical aseptic manipulations to occur in an ISO Class 5 environment. This dictates the entire HVAC design, often requiring 60-100% HEPA filter ceiling coverage and unidirectional airflow.
The core principle of 21 CFR 211 is preventing contamination and mix-ups. We translate this into a physical layout through zoning (creating a cleanroom-within-a-cleanroom), unidirectional flow for personnel and materials, and critical control points like interlocking personnel and material airlocks. The HVAC system reinforces this with pressure cascades, ensuring air flows from cleaner to less-clean areas.
The HVAC system is the primary engineering control for achieving an ISO classification. For ISO 6 and above, we use non-unidirectional (turbulent) flow and high Air Changes Per Hour (ACPH) to dilute and remove contaminants. For the most critical ISO 5 / Grade A zones, we use unidirectional (laminar) airflow, which creates a piston-like effect to physically displace and sweep particles away from the product.
An EM program provides ongoing, documented evidence that a facility remains in a state of control. It monitors both non-viable particulates (with laser counters) and viable microbes (through active air sampling, settle plates, surface monitoring, and personnel gowning plates). Crucially, this monitoring must occur under dynamic, "in-operation" conditions, and the data is used to establish facility-specific Alert and Action Levels to detect any drift from the validated state.
Their core objectives differ. A GMP facility's primary goal is product protection to ensure patient safety; the design focuses on preventing product contamination. An ISO 17025 lab's primary goal is data integrity to ensure valid test results; the design focuses on preventing environmental interference with the measurement (e.g., controlling vibration, EMI, or specific chemical vapors).
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