MEDICAL DEVICE
Chemistry for Medical Device Manufacturing
Medical device manufacturing requires specialized chemistry for precision cleaning to remove machining contamination followed by surface treatment chemistry to prepare the parts for further fabrication. Seacole offers a broad line of aqueous and solvent-based cleaning chemistry to gently remove soils and leave very low levels of unwanted residues behind. Once clean, the surface can be passivated or plated using chemistry also supplied by Seacole.
Benefits:
- Wide variety of cleaning and surface preparation chemistry
to meet any application. - Expert advice and support from an experienced team
of chemists and surface engineers. - Minnesota based manufacturing, customer service
and laboratories.
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Share your medical device chemistry challenges with us, and we will reach out to discuss solutions.
CLEANING
Scroll table to the left to see more data.
| TYPE | PRODUCT | DESCRIPTION | pH | INHIBITORS | RELATIVE RATE OF ATTACK | OPERATING TEMP RATE |
|---|---|---|---|---|---|---|
| AQUEOUS | A590 Soak | Multi-metal liquid burnishing/cleaning product for mass finishing processes | neutral | yes, prevents rust | — | — |
| AQUEOUS & SPRAY CAB | Spraydet EC | Multi-metal silicon-free liquid alkaline detergent for electronic parts, free rinsing | alkaline, 11.5 | — | low | 140-210° F |
| AQUEOUS & ULTRASONIC | Spraydet EL | Multi-metal silicon-free liquid detergent for aqueous part cleaning, electrical safe | alkaline, 12.0 | — | low | 140-210° F |
| AQUEOUS | Spraydet EV | Multi-metal silicon-free liquid detergent for aqueous part cleaning, free-rinsing | alkaline, 12.0 | yes, prevents rust | low | 140-210° F |
| AQUEOUS & ULTRASONIC | Aqua UL | Multi-metal liquid alkaline detergent formulated for ultrasonic cleaning tough soil | alkaline, 10.5 | yes | low | 140-180°F, 160°F optimal |
| FOUNTAIN WASHERS | Aqua Force | Multi-metal liquid alkaline detergent for manual fountain style parts washers | alkaline, 10.5 | yes | low | ambiant to 110°F |
| ULTRASONIC | Sonic Blast | Concentrated multi-metal safe liquid detergent for toughest cleaning | alkaline, 13.2 | yes | low | 140-180°F, 160°F optimal |
| DEFOAMER | Defoamer O | non-silicone liquid foam suppressant to enhance Spraydet products | neutral | no | none | ambiant to 180°F |
| DEFOAMER | Defoamer S | aqueous silicone defoamer | neutral | no | none | ambiant to 180°F |
| SOLVENT | IPA 50%, 70%, 99+% | 99+% SEMI grade IPA, 50% and 70% diluted with RO quality water | — | — | — | — |
| SOLVENT | Acetone | SEMI grade | — | — | — | — |
| SOLVENT | Methanol | SEMI grade | — | — | — | — |
| SOLVENT | Heptane | Technical grade with Seacole GC analysis confirming purity | — | — | — | — |
| SOLVENT | Hexane | 85% and 95% reagent grade | — | — | — | — |
| SOLVENT | Ethanol | Denatured Formula 3A | — | — | — | — |
| SOLVENT | Flourinert Solvents | PFAS/PFOS free | — | — | — | — |
| SOLVENT | Hydrogen Peroxide | 30% SEMI grade, 35% and 50% Technical grade | — | — | — | — |
METAL PASSIVATION / PLATING
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| TYPE | PRODUCT | DESCRIPTION | STRONG ACID | INHIBITORS | RELATIVE RATE OF ATTACK | OPERATING TEMP RATE |
|---|---|---|---|---|---|---|
| STAINLESS STEEL | CitriSurf 2250 | Proprietary blend of chemicals to clean and passivate stainless steel | no | no | low | 120°F - 160°F |
| STAINLESS STEEL | Dynafin 5504 | Proprietary strong acid blend for polishing and passivating stainless | yes | yes | med-high | 160°F - 180°F |
| MULTI METAL | Nitric Acid | 70% strong acid liquid SEMI grade | yes | no | med-high | 100°F - 180°F |
| MULTI METAL | Citric Acid | USP/FCC fine granular | no, organic acid | no | low | 160°F - 180°F |
| PICKLING | Sulfuric Acid | 96% strong acid liquid SEMI grade | yes | no | low | 160°F - 180°F |
| PICKLING | EPS 1378 Stainless Pickle Acid | Proprietary blend for stainless steel pickeling | yes | yes | med | ambient - 110°F |
| PICKLING | Weld Wizard 9350 | Low hazard, low etching proprietary blend for removal of weld discolorization and other scale from stainless steel | no | no | low | 160°F - 180°F |
| PLATING | Electroless Nickel | MetalChem high phos | no | yes | low | 190°F |
| PLATING | Electrolytic Nickel | MetalChem low phos | no | yes | low | 190°F |
Private label Blending & packaging
Whether it’s a Seacole formulation or your proprietary formula, we can blend, package, and label the product with your unique branding.
- Technical chemical team offers R & D support
- Audited Quality Management System
- Seacole is proud to have earned and maintained:
- FDA registered Class 1 manufacturer
- ISO certified 9001-2015
- ACD Responsible Distribution
- DEA Certification
- Liquid blending: 100 to 3000 gallon batches
- Dry blending: 150# to 15,000# batches
- Liquid & Powder filling lines with induction sealer, labeler, lot coders and heat tunnel shrink wrap
- Finished products ship to your warehouse or blind ship to your customer direct
Common Chemical Grades
SEMI-CONDUCTOR
Chemicals that are ultra-purified to parts per billion (ppb) and parts per trillion (ppt) levels for metal ions and organic contaminants. Ultra-filtration ensures low, controlled particulate levels and very low residues after evaporation. This limited list of chemicals adhere to strict quality requirements with specifications established by SEMI for use in the manufacture of semiconductors.
ACS
A large group of ultra-pure, high assay reagent chemicals created for laboratory testing. The American Chemical Society (ACS) establishes the specifications for these products that typically fill small jars on laboratory shelves and are sometimes specified in manufacturing where high purity is required.
USP
A group of chemicals used for Pharmaceutical, food and medical applications. The United States Pharmacopeia sets the specification requirements, which include both chemical and sometimes microbiological testing. These standards ensure that chemicals meet specific criteria for identity, quality, purity, strength, and consistency, primarily for use in active pharmaceutical formulations.
REAGENT
Another term for ACS grade chemicals.
NF
These chemicals are similar to USP. The National Formulary, a publication of the USP, dictates the specifications. These chemicals focus mainly on non-active pharmaceutical ingredients.
LABORATORY
Relatively high purity chemicals with unspecified contaminants suitable for low-level education and training purposes where ACS quality standards are not required.
PURIFIED
Medium to low purity chemicals that do not meet any official standards.
TECHNICAL
Good quality chemicals for use in commercial and industrial applications where purity in not critical. Often manufacturer purity specifications appear high but handling and packaging bring down the quality and consistency.
Isopropyl Alcohol grade comparison
Scroll table to the left to see more data.
| SEMI | USP | ACS (reagent) | TECH (in bulk) | |
|---|---|---|---|---|
| Assay | 99.9-100% | 99% min | 99.5% min | 99% min |
| Color | 5 max | 10 max | 10 max | 10 max |
| 0.2 Particle Count | 250 par/ml max | - | - | - |
| 0.2 Particle Count | 50 par/ml max | - | - | - |
| Specific Gravity @25˚C | - | 0.783-0.787 | - | 0.783-0.787 |
| Appearance | - | clear | - | clear |
| Identification by IR | - | pass | - | - |
| Carbonyl Compounds | - | - | .0025 max | - |
| Water | 20 PPM max | 5000 PPM max | 2000 PPM max | 5000 PPM |
| Acidity | 0.1 UEQ/G max | 0.7 UEQ/G max | 0.1 UEQ/G max | 0.001% |
| Chloride, Phosphate | 50 PPB | - | - | - |
| Residue after evap | 1000 PPB | 50,000 PPB | 10,000 PPB | 10,000 PPB |
| Aluminum, Antimony, Arsenic, Barium, Beryllium, Bismuth, Boron, Cadmium, Calcium, Chromium, Copper, Gallium, Germanium, Gold, Lithium, Magnesium, Molybdenum, Nobidium, Potassium, Silver, Sodium, Strontium, Tantalum, Thallium, Tin, Titanium, Vanadium, Zinc | 1 PPB max | - | - | - |
| Cobalt, Iron, Nickel | 1 PPB max | - | 100 PPB | - |
| Lead | 1 PPB max | - | 1000 PPB | - |
Why Seacole
Customers choose Seacole for our extensive technical expertise, our ability to quickly adapt to new markets, and our wide product range. They appreciate our dedication to environmental sustainability and the safety of our community. We push past the boundaries of innovation to address your toughest chemistry challenges while staying true to your high standards for performance, safety, and sustainability.
Consistent Quality • Customer Focused Technical Support • Experienced Process Expertise
Chemistry solutions for your business challenges.
MEDICAL FAQs
Specialized chemicals are used to deburr metals, remove cutting oils and process contamination to prepare parts for further processing. Chemicals are used to add a surface layer to protect the metal surface from oxidation. Passivation and plating are two examples.
Detergents and solvents are used for cleaning. Acids are used for deburring, surface modification and protection.
The chemicals need to be very pure so no extraneous contamination is introduced during processing. The grade of the chemistry lends consistency, quality assurance and documentation.
There are many regulatory organizations governing chemical quality, safety, handling and environmental stewardship. Seacole follows all regulations and provides auditable processes to help medical device manufacturers meet their own quality requirements.
