Pharma Disks

Pharma Test Disks are certified metal detector test standards purpose-built for validating pharmaceutical metal detection systems. Each disk features a low-density plastic carrier — 15.0mm diameter × 7.0mm thick — with a certified grade 200 precision metal ball visibly enclosed. Along with our Pharma Test Tablets, these disks provide accurate and traceable performance checks for individual dosage and product flow inspection.

Available in Ferrous Chrome, Non-Ferrous Brass, Stainless Steel (SS304, SS316, SS440), and Aluminum. Ball sizes from 0.30mm to 3.50mm.

Disk Specifications and Quality Assurance

Dimensions: 15.0mm diameter × 7.0mm thick low-density plastic disk carrier with integrated precision ball sample
Maximum Ball Size: 3.50mm — the largest precision ball this format accommodates
Ball Size Range: 0.30mm through 3.50mm to match your system's sensitivity specification
Primary Application: Validation of pharmaceutical metal detection systems for individual dosage and product flow inspection
Contaminant Types: Ferrous Chrome (FE, 7.80g/cc), Non-Ferrous Brass (NF, 8.47g/cc), SS316 (7.95g/cc), SS304 (7.95g/cc), SS440 (7.70g/cc), Aluminum (AL, 2.79g/cc)
Traceability: NIST traceable; each disk laser-marked with size, contaminant type, and unique CoC number
Material Compliance: FDA-compliant carrier materials per 21 CFR 177.2470 and 21 CFR 177.3297
Ball Standards: Precision balls meet AMBA, AFBMA, and ISO 3290 tolerances
Design: Low-density carrier is transparent to detection systems — only the enclosed sample is detected
Tamper-Proof: Precision ball is permanently sealed inside the carrier; no user-accessible opening

Frequently Asked Questions

Pharma Test Disks — Pharmaceutical Metal Detector Validation

A Pharma Test Disk is a low-density plastic disk carrier — 15.0mm diameter and 7.0mm thick — with a certified grade 200 precision metal ball permanently enclosed inside. The disk is passed through or alongside the pharmaceutical metal detector aperture. If the system correctly triggers a rejection as the ball passes through the detection zone, the sensitivity check is confirmed. The plastic carrier is transparent to the detection system, so only the enclosed metal ball is detected, accurately simulating a real metal contaminant of a specified size and material type.

Both are pharmaceutical metal detector test standards, but the carrier formats differ. Pharma Test Disks are flat circular carriers — 15.0mm diameter × 7.0mm thick — designed to simulate round or disk-shaped dosage forms or to match specific inspection geometries on certain pharmaceutical detector systems. Pharma Test Tablets are rectangular carriers — 5.0mm × 10.0mm × 25.0mm — designed for tablet or capsule-sized product inspection. Your metal detector manufacturer's validation protocol will specify which format — disk, tablet, or both — is appropriate for your specific system and product line.

The precision ball is a certified grade 200 metal sphere permanently sealed inside the plastic carrier. It is the actual test contaminant — manufactured to tight tolerances in a specific material (Ferrous Chrome, Non-Ferrous Brass, Stainless Steel, or Aluminum) and a specific diameter (the size you select). The ball diameter represents the minimum contaminant size your metal detector must reliably detect. Each disk is laser-marked with its size, contaminant type, and a unique Certificate of Conformance number for audit traceability.

The ball diameter should match the minimum detectable contaminant size specified in your validation protocol or regulatory submission. Pharma Test Disks are available from 0.30mm through 3.50mm. Your pharmaceutical metal detector manufacturer's sensitivity specification sheet and your GMP validation documentation will specify the required detection threshold for each metal type (Fe, NFe, SS). If you are unsure, contact Test Standard Labs for guidance on selecting the correct size for your specific system and regulatory requirements.

Pharma Test Disks are available in Ferrous Chrome / FE (52100 steel, 7.80g/cc), Non-Ferrous Brass / NF (8.47g/cc), Stainless Steel SS316 (7.95g/cc), Stainless Steel SS304 (7.95g/cc), Stainless Steel SS440 (7.70g/cc), and Aluminum / AL (2.79g/cc). Most pharmaceutical validation programs require testing with all three contaminant categories — Fe, NFe, and SS. Stainless steel is the most critical because it is the hardest for metal detectors to reliably detect, especially in pharmaceutical product environments where product effect can influence sensitivity.

Yes. Test Standard Labs Pharma Test Disks are NIST traceable and manufactured from FDA-compliant materials per 21 CFR 177.2470 and 21 CFR 177.3297. They are suitable for metal detector validation programs under FDA 21 CFR Part 211 GMP requirements, USP metal contamination guidelines, EU GMP Annex 11, and ISO 15378 pharmaceutical packaging standards. Each disk carries a unique CoC number and Certificates of Conformance are available to support IQ/OQ/PQ validation documentation and regulatory inspections.

Pharma Test Disks are designed for pharmaceutical metal detection systems used in solid dosage form and product flow inspection. The compact disk format — 15.0mm diameter × 7.0mm thick — is sized to pass through the narrow apertures typical of pharmaceutical conveyor and rotary detectors, and is particularly suited to systems that inspect round or disk-shaped products. For tablet or capsule-shaped products requiring a rectangular carrier format, see the Pharma Test Tablets category. For pipeline or liquid product pharmaceutical inspection, see the Pipeline Rods category.

Yes. All Test Standard Labs products include full traceability documentation. Each Pharma Test Disk is laser-marked with its ball size, contaminant type, and a unique Certificate of Conformance (CoC) number. Full Certificates of Conformance are available with purchase and can be retrieved via the CoC Lookup tool on the Test Standard Labs website. These certificates confirm the disk meets its specified dimensional and material standards and provide the NIST-traceable audit trail required for GMP validation records and regulatory inspection.

Pharmaceutical GMP requirements typically mandate metal detector validation at the start of each production batch, following any line stoppage or equipment adjustment, at product changeover, and at the end of each shift. Some SOPs or regulatory submissions require more frequent checks — every 30 to 60 minutes depending on risk classification and batch size. Your specific validation frequency should be defined in your Site Master File or equipment validation protocol and consistently recorded in your batch records.

Yes. Test Standard Labs Pharma Test Disks are universally compatible with all major pharmaceutical metal detection system brands including Mettler-Toledo (Safeline), Fortress Technology, Loma Systems, Anritsu, Cassel, Minebea Intec, and Thermo Scientific. No proprietary adapters or system-specific configurations are required. The disk format is sized to work with the narrow apertures common across pharmaceutical conveyor detection systems.

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Pharma Disks

Disk Specifications and Quality Assurance

Frequently Asked Questions

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