Evidence map

Use primary references to ask better questions—not to invent a machine.

This site translates published regulatory and hygienic-design references, reviewed on 26 August 2026, into an RFQ structure. It does not claim that an unnamed supplier or machine is certified, compliant, or validated.

E01

U.S. Food and Drug Administration / eCFR

21 CFR Part 113

Definitions and regulatory framework for thermally processed low-acid foods in hermetically sealed containers.

U.S. low-acid canned-food regulation · eCFR current through 24 August 2026 · Reviewed 26 August 2026

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E02

U.S. Food and Drug Administration

Aseptic processing and packaging inspection guide

Sterile-zone boundaries, scheduled-process responsibilities, bag-in-box interfaces, deviations, and records.

U.S. LACF inspection reference · updated 14 July 2005 · Reviewed 26 August 2026

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E03

Codex Alimentarius

CXC 40-1993

Hygienic practice for aseptically processed and packaged low-acid foods.

Codex low-acid-food code · 1993 edition · Reviewed 26 August 2026

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E04

European Hygienic Engineering & Design Group

EHEDG Guideline 46

Planning, installation, qualification, operation, decontamination, and microbiological test context for hygienic and aseptic fillers.

Publisher guideline page; exact equipment scope still requires verification · Reviewed 26 August 2026

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E05

European Hygienic Engineering & Design Group

EHEDG Guideline 50

CIP hygienic design, user requirements, management, and validation context.

Publisher guideline page; not an equipment certification claim · Reviewed 26 August 2026

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E06

U.S. Food and Drug Administration

FDA Form 2541g instructions

A practical map of product factors such as particles, pH, Brix, solids, starches, and flow behavior.

U.S. LACF process-filing input context · Reviewed 26 August 2026

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E07

International Organization for Standardization

ISO 8573-1:2010

Compressed-air purity classes; the required class still depends on use and sampling point.

Compressed-air purity classes · 2010 edition · Reviewed 26 August 2026

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E08

International Electrotechnical Commission

IEC 62381:2024

Project structure for automation FAT, FIT, SAT, and SIT—not proof of food-process sterility.

Automation acceptance-test framework · 2024 edition · Reviewed 26 August 2026

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E09

3-A Sanitary Standards, Inc.

3-A Accepted Practice 605-05

Installation and CIP criteria for processing equipment and hygienic pipelines.

Sixth edition · effective 5 July 2021 · Reviewed 26 August 2026

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PUBLIC CLAIM RULES

What this local candidate refuses to claim.

No manufacturer, factory, team, service-network, patent, certification, or installed-base claim without exact evidence.
No universal throughput, accuracy, viscosity, particle, temperature, utility, or package-fit claim.
No “FDA-approved machine,” “100% sterile,” “zero contamination,” or equivalent absolute claim.
No competitor specification, image, case, or certificate is presented as Site03 capability.
No regulatory guide replaces the buyer’s process authority, risk assessment, or market-specific compliance review.