AGMA Sterile IPA 70% in WFI 900mL Trigger Spray – 6 units
AGMA Sterile Alcohol 70% IPA in WFI 900mL trigger spray (Item 105666) is a proven, ready-to-use disinfection solution for continuous and routine disinfection within pharmaceutical manufacturing facilities and cleanrooms.
This sterile disinfectant combines 70% Isopropyl Alcohol (v/v) with high-purity Water for Injection (WFI grade water) and is 0.2 micron filtered. Thanks to the advanced bag-in-bottle trigger spray system, the sterility of the contents is guaranteed throughout its entire use (validated for 13 weeks of in-use sterility). The alcohol evaporates completely without leaving any residue, making it a cost-effective and reliable choice for complying with the strict requirements of EU GMP Annex 1.
Key Features & Benefits
- Proven Disinfectant Action: Independently validated efficacy for continuous and routine disinfection in critical controlled environments.
- Advanced Bag-in-Bottle System: Maintains liquid sterility during daily use and prevents back-suction of unfiltered air into the bottle (validated 13-week in-use sterility).
- Highest Purity Grade (WFI & 0.2 µm Filtered): Formulated with Water for Injection (WFI grade water) and filtered through a 0.2 micron filter for minimal particulate burden.
- Residue-Free Evaporation: The 70% IPA evaporates rapidly and completely from the surface, leaving no residue and eliminating the need for rinsing.
- Sterile & Double Bagged: Sterilised by gamma irradiation and double bagged for safe and compliant transfer into Grade A/B zones.
- Manufactured under Strict Cleanroom Conditions: Produced in Grade C/D cleanrooms and filled under Grade A laminar airflow conditions in compliance with cGMP guidelines.
- Ergonomic Operation: Features an ergonomic trigger spray equipped with a reliable recoil mechanism.
Specifications
| Feature | Specification |
|---|---|
| Product | AGMA Sterile Alcohol 900mL Trigger Spray (IPA 70% in WFI) |
| Manufacturer Item Number | Item No. 105666 |
| Composition | 70% Isopropyl Alcohol (IPA v/v) / 30% Water for Injection (WFI) |
| Filtration | 0.2 Micron filtered |
| Sterilisation Method | Gamma Irradiated |
| Packaging System | Bag-in-Bottle trigger spray (maintains sterility during use) |
| In-use Validation | 13 weeks validated in-use sterility after opening |
| Transfer Packaging | Double bagged |
| Shelf Life | 2 years |
| Packaging | Box of 6 x 900mL bottles |
| Manufacturing Environment | Manufactured in Grade C/D, filled under Grade A conditions |
| Compliance & Traceability | Supports EU GMP Annex 1 standards; fully traceable with analytical documentation |
Applications & Usage
AGMA Sterile IPA 70% is designed to assist cleanroom operators in complying with EU GMP Annex 1 standards:
- Hard Surfaces: Routine disinfection of cleanroom walls, floors, ceilings, and stainless steel equipment.
- Transfer Processes & Airlocks: Disinfection of materials, tools, and packaging prior to transfer into Grade A/B critical zones.
- Workstation Disinfection: Disinfection of laminar flow hoods, isolators, safety cabinets, and transfer tables (in combination with sterile dry cleanroom wipes).
Instructions for Use:
- Ensure complete wetting of the target hard surface.
- Allow the alcohol to act and evaporate, or wipe off with a sterile dry cleanroom wipe for optimal particle pick-up and even distribution.
- Note: Do not use on alcohol-sensitive surfaces such as acrylic glass (Plexiglas). Always close the spray nozzle after use.
Use biocides safely. Always read the label and product information before use.
