HYPO-CHLOR® Cleanroom Disinfectant

HYPO-CHLOR® is a pharmaceutical cleanroom disinfectant formulated with sodium hypochlorite and Water for Injection (WFI). Designed for pharmaceutical, biotechnology, healthcare and medical device environments, HYPO-CHLOR® is suitable for cleaning rotations where maintaining a clean and critical environment is essential.

HYPO-CHLOR® is available in 0.25%, 0.52% and 5.25% concentrations. The product range includes ready-to-use solutions and a concentrated 5.25% solution.

• Sodium hypochlorite formulated with Water for Injection
• Available in 0.25%, 0.52% and 5.25% concentrations
• Designed for pharmaceutical and critical cleanroom environments
• Filtered at 0.2 microns
• Manufactured using aseptic filling processes
• Available in multiple container sizes
• Lot-specific analytical and sterility data supplied
• Validated for sterility and shelf life
• Suitable for washable, non-porous, hard environmental surfaces

Cleanroom Disinfectant for Critical Environments

HYPO-CHLOR® has been developed for pharmaceutical, biotechnology, healthcare and medical device cleaning rotations that require a sodium hypochlorite solution suitable for maintaining clean and critical environments.

The product is designed for most washable, non-porous, hard and inanimate environmental surfaces. Typical applications include cleanrooms and controlled areas, aseptic filling and gowning rooms, general manufacturing areas and laboratories.

HYPO-CHLOR® can also be used on machinery, tools, tables, counters, laminar-flow benches, floors, walls, carts and shelves, as well as surfaces including plastic, glass, vinyl, glazed porcelain, laminates, glazed tile and stainless steel.

Available Concentrations

HYPO-CHLOR® is available in three concentrations to suit different cleanroom and disinfecting requirements:

• 0.25% – ready-to-use sodium hypochlorite solution
• 0.52% – ready-to-use sodium hypochlorite solution
• 5.25% – concentrated sodium hypochlorite solution

The 5.25% solution can also be diluted to produce 0.25% or 0.52% solutions according to the manufacturer’s specified dilution instructions.

Sterile Pharmaceutical Cleanroom Formula

HYPO-CHLOR® products are formulated using Water for Injection and manufactured with controlled sterile processing. The product is filtered at 0.2 microns and filled in an ISO 5 cleanroom (Grade A).

Components are air washed with 0.2 micron filtered air before the product is aseptically filled into sterile components using gamma irradiation. Each lot is sterility tested according to the current USP compendium and is completely traceable from start to finish.

Sterility and shelf life are validated, and products are supplied with lot-specific analytical and sterility data.

ABCD Cleanroom Introduction System®

HYPO-CHLOR® products use the ABCD Cleanroom Introduction System®, a packaging system designed to help introduce products through different levels of classified areas while protecting the finished product from contamination.

The system uses multiple protective packaging layers. Sterilised groups of containers are contained within two outer bags, while individual containers are additionally packaged within two easy-tear bags.

Product Applications

• Cleanrooms and controlled areas
• Aseptic filling rooms
• Gowning rooms
• General manufacturing areas
• Laboratories
• Machinery and tools
• Tables and counters
• Laminar-flow benches
• Floors and walls
• Carts and shelves
• Plastic, glass and vinyl surfaces
• Glazed porcelain and glazed tile
• Stainless steel

Residue Management

As HYPO-CHLOR® contains sodium hypochlorite, sodium residue can remain on a surface after the product dries. Appropriate residue removal is therefore an important part of the cleaning process.

The manufacturer’s technical data explains that sodium residue can be removed using a hot Water for Injection rinse, mechanical rinsing, or wiping with a dry wipe and isopropyl alcohol such as DEC-AHOL® WFI.

Regular removal of residue helps reduce the potential for surface deterioration, corrosion and pitting, particularly when working with susceptible materials.

Efficacy

HYPO-CHLOR® 0.25% and 0.52% have been tested to certified European EN efficacy standards. Testing supports bactericidal, fungicidal, yeasticidal and sporicidal efficacy under the specified test conditions.

HYPO-CHLOR® 0.25% demonstrated bactericidal efficacy at 6 minutes, fungicidal efficacy at 8 minutes and sporicidal efficacy at 40 minutes. HYPO-CHLOR® 0.52% demonstrated bactericidal and fungicidal efficacy at 6 minutes and sporicidal efficacy at 25 minutes.

Manufacturing and Quality

• Formulated with USP Water for Injection
• Filled in an ISO 5 cleanroom (Grade A)
• Filtered at 0.2 microns
• Components air washed with 0.2 micron filtered air
• Aseptically filled into sterile components via gamma irradiation
• Lot sterility tested according to the current USP compendium
• Completely traceable from start to finish
• Validated for sterility and shelf life

Technical Specifications

Available Sizes

• 473 mL
• 384 mL Unit Dose
• 3.79 L
• 200 L Drum

Not every size is available in every concentration. Please select the available product configuration or contact our team for assistance with the correct HYPO-CHLOR® formulation for your application.

Ordering Information

HYPO-CHLOR® is available in multiple sizes and configurations, with the exact combination of size and concentration varying by product. Contact our team to confirm availability and select the appropriate configuration.

Additional Documentation

Additional documentation is available on request, including product testing reports, product labels, product validation documentation, Safety Data Sheets and sample lot-specific documentation containing analytical and sterility data.

Contact our team for HYPO-CHLOR® product availability, pricing and technical information.