Sterile Cleanroom Pen & Marker

Maintaining strict contamination control within pharmaceutical cleanrooms, sterile processing suites, and biotechnology compounding facilities demands meticulous vigilance down to the smallest stationery item. Standard commercial pens shed thousands of microscopic plastic particles and volatile compounds during normal handling, introducing unacceptable contamination risks into aseptic processing areas. The Sterile Cleanroom Pen and Marker manufactured by Jashmine Unitech Pvt. Ltd. eliminates this vulnerability, delivering verified sterility, zero particulate shedding, and permanent chemical resistance for critical Standard Operating Procedure (SOP) documentation.

Ultra-Low Particulate Polypropylene Construction

Transitioning into classified environments requires materials that do not degrade or release particulates during repetitive sanitization. Every Jashmine Unitech sterile pen marker is constructed with an ultra-pure, high-density polypropylene (PP) barrel and cap. The barrel surface is specially passivated to prevent flaking and cracking when exposed to continuous wiping with 70% Isopropyl Alcohol (IPA), sporicide sprays, or hydrogen peroxide solutions. The tight-fitting cap prevents ink dry-out while incorporating a secure roll-stop design to prevent the pen from rolling off stainless steel cleanroom benches.

Validated Sterility Assurance Level (SAL 10⁻⁶)

Sterility is validated in accordance with ISO 11137 standards. Each production batch undergoes certified Gamma Irradiation processing to achieve a Sterility Assurance Level (SAL) of 10⁻⁶. Following sterilization, units are clean-cut and vacuum-sealed inside high-barrier, double-bagged cleanroom pouches within a certified ISO Class 5 laminar flow environment. This double-layer aseptic packaging allows cleanroom operators to strip the outer pouch at the gowning airlock before transferring the inner sterile pouch directly into Grade A and Grade B laminar flow workstations without breaching the sterile boundary.

Permanent, IPA-Resistant & Non-Smear Ink Chemistry

Cleanroom documentation must withstand frequent sanitization protocols without fading or bleeding. The pen is filled with a specialized, non-toxic, low-outgassing alcohol-based indelible ink. Once applied to cleanroom paper, autoclavable Tyvek® pouches, cryogenic labels, or plastic sample bags, the ink dries within 2 to 3 seconds. It delivers complete resistance against 70% IPA wipe-downs, mild bleach, and deionized water, ensuring that lot numbers, operator initials, and batch record data remain permanently legible.

Technical Specifications

Target Applications & Controlled Environments

• Pharmaceutical Sterile Manufacturing: Batch record logging, autoclave pouch labeling, and SOP sign-offs in Grades A and B aseptic core zones.
• Biotechnology & Cell Culture Labs: Labeling cryogenic vials, petri dishes, and microcentrifuge tubes without ink leaching or toxic outgassing.
• Semiconductor & Microelectronics: Non-contaminating documentation inside ISO Class 4 and 5 wafer fabrication lines.
• Compounding Pharmacies & Hospitals: Cleanroom preparation of parenteral nutrition, oncology medications, and IV admixtures.

Airlock Transfer & Handling Protocol

To preserve cleanroom integrity, remove the outermost pouch in the transition pass-through or material airlock (MAL) using sterile glove technique. Spray or wipe the secondary pouch with sterile 70% IPA before introducing it into the secondary change area or primary laminar flow workstation. Never re-introduce pens that have left controlled zones back into aseptic core areas without re-sterilization.