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Cleanroom Pens (Black or Blue)

Cleanroom Pens (Black or Blue)

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SKU: PEN-01/02 7 - 10 Business Days
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Micronova PEN-01 / PEN-02 Cleanroom Ballpoint Pens - Black or Blue Low-Sodium Ink - 0.7 mm - 10 Pens/Pack or 100 Pens/Case

Micronova Cleanroom Ballpoint Pens are capped writing instruments designed for documentation and labeling in cleanrooms, laboratories, controlled manufacturing facilities and other environments where ordinary office stationery may introduce unwanted contamination. The pens combine low-sodium ballpoint ink with a white high-density polypropylene barrel designed to limit particle generation during appropriate handling.

Two standard non-irradiated configurations are available: PEN-01 with black ink and PEN-02 with blue ink. Both use a 0.7 mm ballpoint tip and measure approximately 5-3/4" long by 3/8" wide. The capped design helps protect the writing tip when the pen is not in use.

Micronova describes the ink as low-sodium and indelible, supporting handwritten cleanroom records, labels, logs, equipment notes and production documentation. Writing performance and permanence must still be evaluated on the actual paper, label or other approved writing substrate, especially when records may contact cleaning solutions.

The white barrel is designed to tolerate exterior wipe-downs with IPA, bleach and phenolic cleaning solutions under suitable conditions. Micronova cautions that thinners and strong solvents can compromise the printed barrel. The manufacturer's exterior wipe-down statement does not establish that the ink written on paper, plastic or labels is resistant to IPA or other cleaning chemicals.

The standard PEN-01 and PEN-02 products are non-irradiated and not autoclavable. Separately identified gamma-irradiated versions are available from Micronova for applications requiring that processing. They should not be confused with the standard black and blue options.

The manufacturer packages 10 pens per inner pack, double-bagged. SOSCleanroom provides an individual 10-pen bag option and a 100-pen case consisting of 10 packs of 10. The case configuration is useful for facilities standardizing one ink color across multiple controlled work areas.

Micronova identifies manufacturer lot numbers on the outer bags and cases, with a Certificate of Conformance available upon request. Maintain the packaging information where documentation or traceability procedures require it.

Cleanroom Documentation Advantage: PEN-01 and PEN-02 combine low-sodium ballpoint ink, a cleanroom-oriented polypropylene barrel, controlled double-bag packaging and manufacturer lot identification. Choose the ink color approved for the record type, and verify writing permanence and cleanability separately.

Specifications:
  • Manufacturer: Micronova Manufacturing, Inc.
  • SOSCleanroom Parent SKU: PEN-01/02
  • Manufacturer Part Number - Black: PEN-01
  • Manufacturer Part Number - Blue: PEN-02
  • Product Type: Capped cleanroom ballpoint pen
  • Ink: Low-sodium ballpoint ink
  • Ink Colors: Black or Blue
  • Barrel: White high-density polypropylene
  • Barrel Design: Intended to limit particle generation
  • Writing Tip: 0.7 mm ballpoint nib
  • Pen Length: 5-3/4" (approximately 146 mm)
  • Pen Width: 3/8" (approximately 9.5 mm)
  • Writing Style: Capped; non-retractable
  • Manufacturer Ink Description: Low-sodium, indelible ink
  • IPA-Resistant Written Markings: Not established for PEN-01 or PEN-02
  • Barrel Wipe-Down Compatibility: Micronova identifies IPA, bleach and phenols
  • Strong Solvent Limitation: Thinners and strong solvents may compromise barrel printing
  • Ink Drying Time: No fixed manufacturer value verified
  • Numerical Sodium Content: Not published in the reviewed model-specific specification
  • Numerical Particle Release: Not published in the reviewed model-specific specification
  • ESD / Antistatic Performance: No electrical rating established
  • Sterility: Standard versions are non-sterile
  • Gamma Irradiation: No, for PEN-01 and PEN-02
  • Autoclavability: Not autoclavable
  • Manufacturer Pack: 10 pens, double-bagged
  • SOSCleanroom Bag Option: 10 pens
  • SOSCleanroom Case Option: 10 packs of 10 pens, 100 total
  • Manufacturer Lot Traceability: Outer bag and case identification
  • Certificate of Conformance: Available upon request
  • Manufacturing Location: Torrance, California, USA
  • Manufacturer Quality System: ISO 9001 certified facility
  • Manufacturer Application: Cleanroom documentation and labeling
  • Numerical ISO Room Rating: Not established for standard PEN-01/PEN-02
  • Published SOS Lead Time: 7-10 business days
  • Original Manufacturer Specification: ENGR-3005 Rev. 00, copyright 2019; archived PDF labeled Revision 001
  • Current Reviewed US SDS: Version 1, issued December 10, 2025
  • SDS Coverage: Includes PEN-01 and PEN-02 ballpoint ink
Black and Blue Model Selection:

Both versions use the same standard capped cleanroom ballpoint construction. The primary model difference is ink color. Select the color required by the facility's approved Good Documentation Practice (GDP), quality, production or maintenance procedure.

Characteristic PEN-01 PEN-02
Ink Color Black Blue
Pen Style Capped ballpoint Capped ballpoint
Nib 0.7 mm 0.7 mm
Barrel White polypropylene White polypropylene
Irradiated No No
Manufacturer Pack 10 pens, double-bagged 10 pens, double-bagged
SOS Case 100 pens 100 pens

Micronova also manufactures PEN-03 with red low-sodium ink. PEN-03 is a separate manufacturer part number and should not be substituted for PEN-01 or PEN-02 without confirming the requested color and product option.

Packaging and Ordering:

The manufacturer's standard non-irradiated cleanroom ballpoint pens are packaged as 10 pens per inner bag, then double-bagged. SOSCleanroom offers a 10-pen pack and a 100-pen case option.

Ordering Unit Configuration Total Pens
Bag / Pack One double-bagged pack 10
SOS Case 10 packs of 10 pens 100

Manufacturer lot identification is printed on the outer packaging and case. Keep the packaging labels when the material must be recorded in receiving, cleaning, controlled-area introduction or quality documentation systems.

Ordering Confirmation: Select black for PEN-01 or blue for PEN-02. Choose the 10-pen pack for smaller requirements or the 100-pen case for facility-wide documentation programs. These options describe non-irradiated pens, not the separately ordered irradiated versions.

About the Manufacturer:

Micronova Manufacturing, Inc. develops cleanroom cleaning tools, stationery, facility accessories and contamination-control consumables for pharmaceutical, biotechnology, semiconductor, medical-device, laboratory and other controlled operations.

Its cleanroom writing-instrument family includes standard and irradiated ballpoint pens, retractable pens, specialized gel pens and LabMarkers. Different models have different ink, packaging and processing characteristics.

SOSCleanroom offers Micronova cleanroom documentation products and provides assistance with selection, manufacturer technical information, case quantities and procurement support.

PEN-01 / PEN-02 Features:
  • Low-sodium ballpoint ink
  • Black PEN-01 and blue PEN-02 options
  • Manufacturer-described indelible writing ink
  • White high-density polypropylene barrel
  • Barrel construction intended to limit particle generation
  • Capped ballpoint design
  • 0.7 mm writing tip
  • Approximately 5-3/4" pen length
  • Exterior barrel compatible with specified IPA, bleach and phenol wipe-downs
  • Designed for cleanroom documentation and labeling tasks
  • Non-irradiated standard product configuration
  • Not autoclavable
  • 10 pens per double-bagged pack
  • 100-pen SOSCleanroom case option
  • Manufacturer lot identification
  • Certificate of Conformance available upon request
PEN-01 / PEN-02 Benefits:
  • Controlled Documentation: Provides a standardized writing instrument for approved cleanroom paperwork.
  • Defined Ink Colors: Supports facility-specific black or blue ink documentation requirements.
  • Low-Sodium Ink: Uses the manufacturer's cleanroom-oriented writing formulation.
  • Reduced Particle-Generation Intent: The specialized polymer barrel is designed to limit contamination contribution compared with uncontrolled writing instruments.
  • Barrel Cleanability: Supports appropriate exterior cleaning during routine handling.
  • Protected Writing Tip: A cap helps limit tip contact with surrounding equipment and surfaces.
  • Double-Bagged Packaging: Supports controlled receiving and material-introduction procedures.
  • Traceability: Manufacturer lot identification assists material control where required.
  • Defined Purchasing Quantities: Choose 10 pens or a 100-pen case.
Common Applications:
  • Production logbooks and equipment records
  • Cleanroom documentation sheets
  • Batch-related written notes where approved
  • Maintenance and inspection checklists
  • Laboratory documentation
  • Material staging and receiving records
  • Equipment-use and cleaning logs
  • Manufacturing travelers and work instructions
  • Quality-control documentation
  • Controlled-area labeling on suitable writing surfaces
  • Handwritten notes on approved cleanroom paper
  • Documentation during inspection and maintenance operations
Low-Sodium Ink and Writing Performance:

Micronova specifies low-sodium ink for PEN-01 and PEN-02 and describes it as indelible. These are manufacturer product characteristics, not a guarantee of identical marking performance on every type of paper, label, plastic or other writing substrate.

  • Ink Selection: Use black or blue according to the approved record or labeling requirement.
  • Low-Sodium Description: No numerical sodium concentration or test method was established from the reviewed original specification.
  • Indelible Claim: Confirm actual permanence on the chosen documentation material.
  • Ink Drying: Allow the writing to dry before stacking, handling, scanning or cleaning nearby surfaces.
  • Cleanroom Paper: Verify smooth writing, legibility and any required archival performance.
  • Labels and Plastic Surfaces: Test compatibility before treating the pen as a substitute for a specialized marker.
  • IPA Exposure: No PEN-01/PEN-02-specific IPA-resistant written-mark qualification was established.
  • Disinfectant Exposure: Do not assume the writing resists bleach, phenolics, peroxide, sporicides or other chemistries.
  • Particle and Ionic Limits: Obtain manufacturer evidence when a process requires quantified acceptance limits.

Ink Selection Guidance: PEN-01 and PEN-02 are cleanroom ballpoint pens for documentation. When labeling bags or labware that will undergo IPA wipe-down, consider the separately specified PEN-40 LabMarker and verify the ink against the actual cleaning method.

Barrel Cleanability and Solvent Limitations:

Micronova identifies compatibility of the exterior barrel with wipe-downs using IPA, bleach and phenols. This helps support controlled-area cleaning of the pen exterior, but does not authorize unlimited soaking or exposure to every disinfectant formulation.

  • IPA Wipe-Down: The manufacturer's compatibility statement applies to the exterior pen barrel.
  • Bleach and Phenols: Exterior compatibility is reported; apply only site-approved concentrations and methods.
  • Strong Solvents: Thinners and aggressive solvents may damage printed barrel identification.
  • Tip Protection: Keep the cap installed during exterior cleaning when practical.
  • Excess Liquid: Avoid saturating the cap, ballpoint assembly and seams.
  • Surface Inspection: Remove pens with damaged barrels, degraded printing, cracks, leakage or loose components.
  • Drying: Allow the exterior to dry before returning to approved storage or use.
  • Ink Resistance: Exterior barrel compatibility must not be used as evidence that written marks resist the same chemicals.

Critical Distinction: The pen barrel tolerating an IPA wipe-down does not mean that PEN-01/PEN-02 ballpoint writing is IPA resistant. Qualify written markings separately wherever solvent exposure could affect records or labels.

Recommended Cleanroom Documentation Procedure:

The following general practices support controlled documentation handling. Follow the facility's approved material-introduction, Good Documentation Practice and contamination-control procedures.

  1. Confirm the Model: Verify PEN-01 black or PEN-02 blue according to the approved documentation requirement.
  2. Inspect Packaging: Check the double-bagged pack and manufacturer lot identification.
  3. Introduce the Material: Follow approved cleanroom transfer and outer-bag removal procedures.
  4. Inspect the Pen: Check cap, barrel, nib and ink condition before use.
  5. Clean as Approved: Wipe the capped exterior using the qualified facility cleaning method.
  6. Allow Drying: Do not introduce unnecessary cleaning liquid into the nib assembly.
  7. Use Approved Paper: Write only on the record or label material designated by the process.
  8. Maintain Legibility: Write clearly and avoid smearing during immediate handling.
  9. Follow GDP: Use site-approved methods for entries, corrections, dates and signatures.
  10. Protect the Tip: Replace the cap after writing.
  11. Store in a Designated Location: Keep the pen away from abrasive tools, dirty surfaces and uncontrolled office stationery.
  12. Inspect After Cleaning: Replace damaged, leaking or visibly degraded pens.
  13. Preserve Traceability: Retain the corresponding lot information where required.
  14. Dispose Correctly: Follow applicable site procedures, including the current SDS where relevant.

Documentation Guidance: A cleanroom-designated pen supports controlled writing practices but does not make a record automatically compliant with GDP, GMP, data integrity or archival requirements. Those must be satisfied by the full documentation process.

Non-Irradiated vs. Irradiated Cleanroom Pens:

The standard PEN-01 and PEN-02 models are non-irradiated. Micronova separately identifies irradiated versions with different manufacturer part numbers and, in some cases, different individual packaging configurations.

Model Ink Irradiated Selection Note
PEN-01 Black No Standard cleanroom documentation
PEN-02 Blue No Standard cleanroom documentation
PEN-01IR Black Yes Separate irradiation and documentation requirements
PEN-02IR Blue Yes Separate irradiation and documentation requirements

Do not substitute a standard non-irradiated pen when the approved process requires irradiated material. Confirm irradiation specifications, certificates, packaging and sterility requirements for the exact irradiated model.

Ink Safety and EHS Documentation:

Micronova's current US Safety Data Sheet for PEN-01 and PEN-02 addresses the ballpoint ink mixture. Its classifications must be considered when an ink-containing pen is damaged, leaks, or requires formal chemical hazard review.

  • Manufacturer SDS: Version 1, issued December 10, 2025.
  • Applicable Product Codes: Includes PEN-01 and PEN-02.
  • SDS Signal Word: Danger.
  • Skin Irritation: Category 2; H315.
  • Serious Eye Damage: Category 1; H318.
  • Reproductive Toxicity: Category 1B; H360.
  • Respiratory Irritation: STOT Single Exposure Category 3; H335.
  • Identified Ink Constituents: 2-Phenoxyethanol and N-methyl-2-pyrrolidone.
  • Routine Use: Avoid deliberate contact with ink, broken tips, leaks and contaminated surfaces.
  • Damaged Pens: Follow the current SDS and facility EHS procedures for handling and disposal.
  • Ventilation and PPE: Apply precautions appropriate to the task and exposure assessment.
  • Qualification: Review the SDS before adding the pens to applications with special chemical restrictions.

Important Safety Notice: The SDS hazard classifications describe the ink formulation and must not be interpreted as measured exposure during ordinary writing with an intact pen. Follow the manufacturer SDS and facility EHS requirements, especially for damaged or leaking pens.

PEN-01 / PEN-02 Compared with PEN-40 IPA-Resistant LabMarker:
Characteristic PEN-01 / PEN-02 PEN-40 LabMarker
Writing Instrument Capped ballpoint pen Fine-tip marker
Ink Colors Black or blue Black
Primary Use Paper documentation and compatible labeling Plastic bags, laboratory items and compatible labels
Ink Description Low-sodium, indelible Permanent, quick-drying, alcohol-resistant
IPA-Resistant Writing Claim Not established Manufacturer-described, subject to surface and process qualification

Selection Guidance: Use PEN-01 or PEN-02 for approved handwritten documentation. Use the separately specified PEN-40 LabMarker where the application calls for alcohol-resistant markings, after testing on the actual label or labware surface. Do not transfer PEN-40 ink-performance claims to PEN-01 or PEN-02.

Storage, Handling and Disposal:
  • Models: PEN-01 black or PEN-02 blue
  • Standard Package: 10 pens, double-bagged
  • SOS Case Option: 100 pens
  • Receiving: Verify model, color, packaging and manufacturer lot information
  • Storage: Follow the manufacturer SDS and applicable site requirements
  • Contamination Control: Keep capped and protected from abrasive contact
  • Exterior Cleaning: Use approved IPA, bleach or phenol procedures compatible with the barrel
  • Strong Solvents: Avoid exposure that may degrade barrel printing
  • Damage Inspection: Remove pens with cracks, leakage, loose caps or deteriorated surfaces
  • Sterility: Standard PEN-01 and PEN-02 are non-irradiated
  • Autoclave: Not autoclavable
  • Shelf Life: No standard PEN-01/PEN-02 numerical shelf life confirmed in the reviewed specification
  • Disposal: Follow applicable waste and ink SDS procedures
Manufacturer Technical Documents:

Micronova Cleanroom Ballpoint Pen Product Information: View Manufacturer Product Page and PEN-01 / PEN-02 Models

Micronova Pens and Markers Catalog: View Current Manufacturer Product Configurations

Micronova US Ballpoint Pen Ink SDS - Version 1, December 10, 2025: View Manufacturer Safety Data Sheet (PDF)

Micronova Safety Data Sheet Library: View Available US and International SDS Documents

The archived exact-model product specification is identified as ENGR-3005 Rev. 00 (2019), with an indexed PDF labeled Revision 001. Its former direct download is unavailable; obtain the current revision directly from Micronova when a revision-controlled document is required.

Other Similar Products Available From SOSCleanroom.com

Cleanroom Documentation and Marking Alternatives

Notes: Need assistance selecting black or blue cleanroom pens, confirming 10-pen versus 100-pen ordering quantities, or choosing between documentation pens and IPA-resistant LabMarkers? SOSCleanroom provides product-selection assistance, manufacturer documentation resources and cleanroom supply procurement support.

SOSCleanroom.com supports pharmaceutical, biotechnology, semiconductor, medical-device, laboratory and other controlled environments with cleanroom stationery, documentation materials, marking supplies and contamination-control products.

Product description updated: November 6, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault By SOSCleanroom
Micronova PEN-01 / PEN-02 Black / Blue Ink Low-Sodium Ink Capped Ballpoint 0.7 mm Tip High-Density Polymer Barrel IPA / Bleach / Phenol Exterior Wipe-Down Double-Bagged 10 Pens / Pack 100 Pens / Case Nonirradiated Not Autoclavable
Micronova Cleanroom Pens: PEN-01 Black and PEN-02 Blue low-sodium ballpoint writing instruments

Micronova PEN-01 and PEN-02 Cleanroom Ballpoint Pens are capped writing instruments designed for documentation in cleanrooms, laboratories and controlled manufacturing environments.

Each pen features low-sodium ballpoint ink, a white high-density polymer barrel and a 0.7 mm writing tip. The manufacturer designs the barrel to help limit particle generation associated with conventional writing instruments.

Two ink colors are identified by the exact manufacturer part numbers: PEN-01 contains black ink, while PEN-02 contains blue ink. Both use the same capped construction and manufacturer packaging format.

The pen exterior is designed to tolerate appropriate wipe-down with IPA, bleach and phenolic cleaning solutions. Strong solvents and thinners may damage printed information on the barrel. Exterior cleanability does not establish alcohol resistance of writing deposited onto paper, labels or containers.

The standard manufacturer presentation contains 10 pens per double-bagged pack. SOSCleanroom offers both a 10-pen pack and a case configuration of 10 packs, totaling 100 pens.

Operations takeaway: PEN-01 and PEN-02 are nonirradiated, capped ballpoint pens for controlled-environment documentation. Their cleanroom-oriented barrel and packaging support material-control procedures, but they are not sterile, autoclavable or automatically qualified for IPA-resistant writing.

Manufacturer specifications and exact model identification
  • Manufacturer: Micronova Manufacturing, Inc.
  • Product family: Cleanroom Ballpoint Pens
  • PEN-01: Black ink
  • PEN-02: Blue ink
  • Additional family color: PEN-03 Red, separately identified
  • Pen style: Capped ballpoint
  • Ink: Low-sodium formulation
  • Barrel: White, high-density polymer
  • Manufacturer barrel description: High-density polypropylene
  • Nominal pen length: 5¾ inches
  • Nominal barrel diameter: 3/8 inch
  • Tip size: 0.7 mm
  • Primary purpose: Cleanroom documentation and labeling
  • Standard packaging: 10 pens per double-bagged pack
  • SOS case configuration: 10 packs, 100 pens total
  • Individual pen bagging: Not provided for standard PEN-01/PEN-02
  • Irradiation: No
  • Autoclavability: No
  • Lot identification: Outer bag and case
  • Certificate of Conformance: Available on request

Model distinction: PEN-01 is Black and PEN-02 is Blue. Red belongs to PEN-03. Irradiated pens and retractable click pens use different manufacturer part numbers and must not be substituted solely on the basis of ink color.

Cleanroom pen construction and contamination-control design
  • Barrel: High-density polymer designed to help limit particle generation.
  • Color: White barrel for visible inspection and identification.
  • Ink: Low-sodium formulation.
  • Writing mechanism: Ballpoint.
  • Cap: Protects the writing tip when not in use.
  • Tip: 0.7 mm nominal size.
  • Handling: Avoid abrasion against rough tools and work surfaces.
  • Contamination transfer: Control movement between rooms and documentation stations.
  • Maintenance: Remove pens with cracked barrels, damaged tips or leaking ink.

Cleanliness distinction: A high-density polymer barrel helps support low-particle-use objectives but does not guarantee zero shedding, zero extractables or freedom from contamination after repeated handling.

Low-sodium ink: what the claim does and does not establish
  • Manufacturer claim: Low-sodium ink.
  • Ink colors: Black or Blue for this listing.
  • Intended purpose: Controlled-environment records and labels.
  • Numerical sodium concentration: No exact concentration established in the model specification.
  • Total ionic extractables: No numerical product-release limit established.
  • Dry-time specification: No exact maximum established.
  • Smear-resistance value: No numerical controlled value established.
  • IPA-resistant written ink: Not established for PEN-01/PEN-02.
  • Permanent-document qualification: Depends on the actual substrate, handling and facility procedure.

Ink limitation: Low-sodium does not mean sodium-free or ion-free. It also does not mean the deposited writing is guaranteed resistant to IPA, bleach, oxidizers or repeated wet cleaning.

Capped 0.7 mm ballpoint versus retractable and marker products
  • PEN-01: Capped, Black, 0.7 mm ballpoint.
  • PEN-02: Capped, Blue, 0.7 mm ballpoint.
  • PEN-11: Separate retractable Black cleanroom click pen.
  • PEN-12: Separate retractable Blue cleanroom click pen.
  • PEN-40: Separate LabMarker with manufacturer IPA-resistant ink positioning.
  • Ballpoint writing: Intended for appropriate paper and documentation tasks.
  • Marker writing: May be selected for compatible laboratory surfaces and labels.
  • Substitution: Match ink performance, style, packaging and irradiation requirements.

Family control: PEN-01/PEN-02 must not be described as PEN-40 IPA-resistant LabMarkers. The writing mechanism, ink-performance claim and intended marking surfaces differ.

Packaging: 10 pens per double-bagged pack
  • Standard manufacturer unit: Ten pens.
  • Packaging presentation: Double bagged.
  • Individual pen bagging: No.
  • Black SKU: PEN-01.
  • Blue SKU: PEN-02.
  • Outer bag: Manufacturer lot identification.
  • Case: Manufacturer traceability information.
  • Material introduction: Follow controlled transfer procedures.
  • Pack integrity: Inspect before entry or release for use.

Packaging clarification: Ten pens per double-bagged pack means the pens are grouped within the manufacturer packaging. Standard PEN-01 and PEN-02 are not individually bagged.

Bag versus case: avoiding purchasing errors
  • Bag purchase: 10 pens.
  • Case purchase: 100 pens.
  • Case calculation: 10 packs of 10 pens.
  • Ink color: Select Black or Blue.
  • Manufacturer SKU: Match the exact color.
  • Order confirmation: Verify the quantity and color.
  • Receiving: Check received pack and case counts.
  • Replenishment: Plan quantities by workstation and documentation consumption.
  • Traceability: Record the applicable manufacturer lot where required.

Ordering control: One pack = 10 pens; one SOS case = 100 pens. The case quantity does not change the pen's nonirradiated status or the need to select the correct manufacturer part number.

Exterior wipe-down: IPA, bleach and phenolic cleaning agents

Micronova identifies the pen barrel as suitable for wipe-down with IPA, bleach and phenolic cleaning agents under appropriate use conditions.

  • IPA: Manufacturer-supported exterior wipe-down compatibility.
  • Bleach: Manufacturer-supported exterior wipe-down compatibility.
  • Phenols: Manufacturer-supported exterior wipe-down compatibility.
  • Strong solvents: May compromise printed barrel information.
  • Thinners: Avoid unqualified exposure.
  • Pen cap: Keep fitted during exterior cleaning.
  • Writing tip: Avoid uncontrolled immersion or chemical saturation.
  • Cleaning method: Use the facility's approved wipe-down procedure.
  • Repeated cleaning: Inspect the barrel, printing and pen function.
  • Drying: Allow suitable drying before returning the pen to documentation use.

Compatibility distinction: Exterior barrel tolerance does not prove that written ink will survive disinfectant wiping. Test legibility separately when records, labels or packaging may be exposed to cleaning chemicals.

Written-ink durability and documentation qualification
  • Primary application: Handwritten cleanroom documentation.
  • Writing substrates: Qualify the approved paper or label surface.
  • Dry time: Verify under actual temperature and humidity conditions.
  • Smudging: Evaluate handling with cleanroom gloves.
  • Page stacking: Avoid transferring wet writing to adjacent pages.
  • IPA exposure: No PEN-01/02 writing-resistance guarantee established.
  • Bleach exposure: No deposited-ink durability guarantee established.
  • Water exposure: Qualify where records may become damp.
  • Archival requirements: Validate according to the document-retention procedure.
  • Critical labels: Use an approved marker and substrate combination when required.

Documentation control: The manufacturer describes the ink as low-sodium and indelible, but the performance of a written record depends on the actual paper, surface, drying, handling and chemical exposure. Avoid assuming universal solvent resistance.

Manufacturer SDS: ink composition and hazard communication

Micronova's United States Safety Data Sheet, issued December 10, 2025, expressly includes PEN-01 and PEN-02. It identifies hazards associated with the ballpoint ink mixture.

  • SDS issue date: December 10, 2025.
  • SDS version: 1.
  • Covered SKUs: Includes PEN-01 and PEN-02.
  • Identified component: 2-Phenoxyethanol.
  • Identified component: N-methyl-2-pyrrolidone (NMP).
  • H315: Causes skin irritation.
  • H318: Causes serious eye damage.
  • H360: May damage fertility or the unborn child.
  • H335: May cause respiratory irritation.
  • Signal word: Danger.
  • Exposure control: Avoid contact with ink and follow applicable SDS precautions.
  • Damaged pens: Handle leaking or broken pens using the facility's chemical-safety procedure.
  • Disposal: Follow applicable regulations and site requirements.

EHS distinction: The SDS characterizes the ink mixture. The listed hazards do not mean a sealed, intact pen necessarily creates the same exposure as spilled or directly handled ink. Review the SDS for procurement, occupational safety and incident-response requirements.

Avoiding ink leaks, direct exposure and damaged pens
  • Before use: Inspect for a cracked barrel or loose components.
  • Writing tip: Check for excessive ink accumulation.
  • Cap: Replace after writing.
  • Storage: Avoid crushing or bending the barrel.
  • Direct skin contact: Avoid contact with free ink.
  • Eye exposure: Follow SDS first-aid instructions.
  • Ink leakage: Isolate the pen and clean under the approved chemical procedure.
  • Contaminated gloves: Replace or clean as required by the facility SOP.
  • Disposal: Follow EHS guidance for damaged ink-containing products.

Failure response: Do not continue using a cracked or leaking pen. A damaged writing instrument can introduce ink residue, liquid exposure and foreign material into a controlled environment.

Nonirradiated status and sterilization limitations
  • PEN-01: Nonirradiated.
  • PEN-02: Nonirradiated.
  • Finished-product sterility: No sterile claim.
  • Autoclavability: Not autoclavable.
  • Irradiated Black alternative: PEN-01IR.
  • Irradiated Blue alternative: PEN-02IR.
  • Additional processing variants: May have different individual bagging and certificate requirements.
  • Critical aseptic use: Must follow the applicable material-qualification and entry procedures.
  • Lot certificates: Obtain the exact product-specific records where required.

Sterility limitation: Standard PEN-01 and PEN-02 are not irradiated or identified as sterile. Do not apply irradiation certificates or sterile claims from PEN-01IR or PEN-02IR to the standard pens.

ISO cleanroom application versus numerical cleanliness evidence
  • Manufacturer intent: Documentation in cleanrooms and controlled environments.
  • Barrel design: Intended to help limit particle generation.
  • Numerical particle-release limit: Not established in the exact-model specification.
  • Numerical fiber-release limit: Not established.
  • Numerical sodium concentration: Not established.
  • Complete ionic extractables: Not established.
  • Product-specific ISO Class certification: Not established by the reviewed model specification.
  • Controlled room qualification: Determined independently from the pen.
  • Facility use: Subject to the contamination-control strategy and applicable SOP.

Qualification principle: A cleanroom-oriented pen is not automatically qualified for every ISO classification or contamination-sensitive process. Request numerical manufacturer evidence if specific particle, ionic or material limits are mandatory.

Best-practice cleanroom material introduction
  1. Confirm the order: Verify PEN-01 Black or PEN-02 Blue.
  2. Check packaging: Inspect the double-bagged pack.
  3. Verify traceability: Record the manufacturer lot when required.
  4. Follow entry controls: Transfer through the approved material route.
  5. Remove outer packaging: Follow the facility's defined stage and method.
  6. Inspect the pens: Check for damage or ink leakage.
  7. Apply approved exterior cleaning: Wipe down the capped pen as required.
  8. Allow drying: Avoid bringing unnecessary moisture to records.
  9. Assign the pen: Use a designated documentation zone or workstation.
  10. Maintain segregation: Avoid mixing pens between areas without authorization.

Material-entry control: Double bagging supports controlled transfer, but does not independently sterilize or disinfect the pen. Follow the actual facility transfer and cleaning procedure.

Best-practice documentation and writing procedure
  1. Verify pen color: Use the approved ink for the record.
  2. Inspect the writing tip: Check for buildup or leakage.
  3. Confirm the writing surface: Use approved paper or documentation material.
  4. Write legibly: Follow the facility's Good Documentation Practice requirements.
  5. Avoid wet gloves: Reduce smearing and transfer.
  6. Allow writing to dry: Prevent offset onto adjacent pages.
  7. Keep the pen clean: Avoid contact with dirty benches and equipment.
  8. Replace the cap: Protect the nib when writing is complete.
  9. Store in the assigned location: Prevent cross-zone transfer.
  10. Dispose of damaged material: Follow the applicable EHS and contamination-control procedure.

GDP guidance: Select an approved writing instrument and record material, write clearly and test any required permanence or cleaning resistance. The pen's manufacturer description alone does not validate an entire documentation system.

PEN-01/PEN-02 versus PEN-40 IPA-resistant LabMarkers
  • PEN-01: Black low-sodium ballpoint ink.
  • PEN-02: Blue low-sodium ballpoint ink.
  • PEN-40: Separate fine-tip LabMarker with IPA-resistant ink characteristics.
  • Ballpoint pen: Selected for suitable documentation paper and records.
  • LabMarker: Selected for appropriate labels, bags and laboratory surfaces.
  • PEN-01/PEN-02 barrel: May be wiped with IPA, bleach and phenols.
  • PEN-01/PEN-02 writing: No universal IPA-resistance claim established.
  • PEN-40 ink: Manufacturer provides a distinct IPA-resistance claim.
  • Cleaning exposure: Verify the actual marked surface and procedure.
  • Substitution: Follow change control when documentation permanence matters.

Selection distinction: Cleanable pen barrel and IPA-resistant written mark are different properties. Use the exact product whose documented ink characteristics match the intended record or labeling application.

Related Micronova pen families and irradiation options
  • PEN-01: Capped Black, nonirradiated.
  • PEN-02: Capped Blue, nonirradiated.
  • PEN-03: Capped Red, separate manufacturer variant.
  • PEN-01IR: Irradiated Black version.
  • PEN-02IR: Irradiated Blue version.
  • PEN-11: Retractable Black cleanroom click pen.
  • PEN-12: Retractable Blue cleanroom click pen.
  • PEN-40: IPA-resistant LabMarker family.
  • Package differences: Verify exact bagging and case quantities.
  • Quality documents: Confirm irradiation and lot processing for applicable variants.

Purchasing principle: Do not transfer irradiation, packaging or chemical-resistance properties between similar Micronova pen families. The exact part number defines the product being ordered.

Storage, segregation and traceability
  • Original packaging: Keep protected until controlled introduction.
  • Caps: Keep fitted when pens are not in use.
  • Storage: Use a clean designated documentation station or container.
  • Solvents: Avoid aggressive chemicals that may damage barrel printing.
  • Mechanical abrasion: Avoid storage against sharp tools.
  • Ink leakage: Inspect and remove compromised pens.
  • Zone segregation: Follow assigned pen-use areas.
  • Lot information: Retain outer packaging records when required.
  • Certificate of Conformance: Request according to the quality program.
  • Fixed shelf-life limit: No standard PEN-01/PEN-02 period established in the reviewed exact-model specification.

Traceability distinction: Micronova identifies lot numbers on the outer bag and case, not on every individual standard pen. Preserve packaging records where the quality system requires lot linkage.

Common failure modes and corrective practices
  • Wrong ink color: Verify PEN-01 or PEN-02.
  • Red option selected: Recognize it as separate manufacturer SKU PEN-03.
  • Ink smearing: Check substrate, drying and glove moisture.
  • Written marks affected by IPA: Use a separately qualified marking system.
  • Barrel print damage: Avoid strong solvents and thinners.
  • Loose cap: Replace securely after use.
  • Cracked barrel: Remove from use.
  • Ink leakage: Apply the approved chemical incident procedure.
  • Uncontrolled room transfer: Assign pens to approved zones.
  • False sterile assumption: Standard variants are nonirradiated.
  • Incorrect case order: Distinguish 10-pen packs from 100-pen cases.
  • Undocumented cleanliness claim: Obtain controlled test evidence.
When PEN-01 or PEN-02 is not the correct selection
  • Sterile or irradiated product required: Evaluate a separate qualified variant.
  • Autoclaving required: Standard pens are not autoclavable.
  • IPA-resistant writing mandatory: Select a product with an appropriate verified ink claim.
  • Marking plastics or glass: Evaluate a suitable LabMarker or other approved marker.
  • Retractable tip required: Consider the relevant click-pen variant.
  • Specific ISO particle limits mandatory: Request controlled numerical evidence.
  • Archival performance mandatory: Qualify the actual ink and paper combination.
  • Visible pen damage: Remove from controlled use.
  • Ink chemical exposure prohibited: Follow the facility's EHS material-selection controls.

Selection limitation: A cleanroom-oriented pen is not universally acceptable for every sterile, residue-sensitive, archive-controlled or chemically exposed documentation process. Match the exact product to the process requirement.

Related cleanroom documentation products

System selection: Compare ink durability, substrate compatibility, barrel cleanability, packaging, irradiation status and the requirements of the actual documentation procedure before standardizing cleanroom stationery.

Why purchase Micronova Cleanroom Pens from SOSCleanroom
  • Exact product selection: PEN-01 Black and PEN-02 Blue.
  • Controlled packaging: Double-bagged 10-pen packs.
  • Flexible purchasing: Bag or 100-pen case options.
  • Cleanroom documentation support: Assistance selecting writing and labeling products.
  • Manufacturer resources: Product specifications, current SDS and available Certificates of Conformance.
  • Customer assistance: Contact SOSCleanroom for availability, technical documents and ordering support.
Manufacturer documentation and authoritative references
  • SOSCleanroom PEN-01 / PEN-02 Product Page: Click Here
  • Micronova Official Capped and Click Cleanroom Ballpoint Pens: Click Here
  • Micronova Cleanroom Pens and Markers Product Selection: Click Here
  • Micronova PEN-01/PEN-02 US Safety Data Sheet — Version 1, December 10, 2025: Click Here
  • Micronova Safety Data Sheet Library: Click Here
  • Micronova Technical Data Sheet Library: Click Here

Technical documentation: Micronova identifies PEN-01 as Black and PEN-02 as Blue, both using low-sodium ink, a capped 0.7 mm ballpoint tip and a white high-density polymer barrel. Standard packs contain 10 pens in double-bagged packaging; SOSCleanroom also offers a 100-pen case. These models are nonirradiated and not autoclavable. The manufacturer supports wipe-down of the barrel with IPA, bleach and phenols, but warns that thinners and strong solvents can damage its printed surface. Barrel cleanability does not establish resistance of written ink to those chemicals. The current manufacturer US SDS, issued December 10, 2025, identifies the ink's relevant chemical hazards and should be consulted for handling, damaged pens and disposal. Numerical cleanliness limits and a current downloadable revision-controlled exact-model specification require further manufacturer evidence.

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