HPS x CMP SteriPack Triple Wrapped Media | Gamma-Irradiated Cleanroom Media for Environmental Monitoring Compliance
The HPS x CMP SteriPack Triple Wrapped Media series is purpose-engineered for environmental monitoring (EM) programmes in pharmaceutical cleanrooms, medical device manufacturing, and biotech facilities. Manufactured by Creative Life Science Co., Ltd. (CMP®) under ISO 13485 GMP standards and gamma (γ)-irradiation sterilized, each plate undergoes growth promotion testing that meets USP and EP pharmacopoeial requirements.
The triple packaging design ensures plates remain sterile and contamination-free until the moment of use — critical for ISO 5 cleanroom and gowning room handling procedures.
Key Features
- γ-Irradiation sterilized — guaranteed sterility assurance for each plate
- Triple-wrapped packaging — easy to open, contamination-free in cleanroom conditions
- Growth promotion meets USP & EP requirements — with neutralizers to prevent false-negative results
- 90mm settle plates for passive air sampling and 55mm contact plates for surface and personnel monitoring
- Neutralizer options: Lecithin (Lec.), Polysorbate 80 (P80), Lactamator (Lac.), Penase, Histidine (His.), Sodium Thiosulphate (Na₂S₂O₃), and 4-neutralizer combinations
Settle Plates (90mm)
| Item Description | Specification | Catalog No. |
|---|---|---|
| SteriPack TSA, Triple | 90mm Mono, 40 or 100 PC/BOX | CMP0800011 / CMP0800012 |
| SteriPack TSA w/Lec. and P80, Triple | 90mm Mono, 100 PC/BOX | CMP0800192 |
| SteriPack TSA w/Lec., P80, and Lac. 1U, Triple | 90mm Mono, 100 PC/BOX | CMP0800212 |
| SteriPack TSA w/Lec., P80, and Penase, Triple | 90mm Mono, 100 PC/BOX | CMP0800182 |
| SteriPack TSA with 4 Neutralizers, Triple (Lec., P80, His, Na₂S₂O₃) | 90mm Mono, 100 PC/BOX | CMP0800142 |
| SteriPack SDA, Triple | 90mm Mono, 40 PC/BOX | CMP0800051 |
Contact Plates (55mm)
| Item Description | Specification | Catalog No. |
|---|---|---|
| SteriPack Contact TSA, Triple | 55mm Contact, 40 PC/BOX | CMP0800021 |
| SteriPack Contact TSA w/Lec. and P80, Triple | 55mm Contact, 40 or 100 PC/BOX | CMP0800041 / CMP0800042 |
| SteriPack Contact TSA w/Lec., P80, and Lac. 1U, Triple | 55mm Contact, 100 PC/BOX | CMP0800092 |
| SteriPack Contact TSA w/Lec., P80, and Penase, Triple | 55mm Contact, 100 PC/BOX | CMP0800072 |
| SteriPack Contact TSA with 4 Neutralizers, Triple (Lec., P80, His, Na₂S₂O₃) | 55mm Contact, 100 PC/BOX | CMP0800112 |
Lec: Lecithin | P80: Polysorbate 80 | Lac: Lactamator | His: Histidine | Na₂S₂O₃: Sodium Thiosulphate
Applications
- Pharmaceutical GMP Cleanroom Environmental Monitoring
- Medical Device Manufacturing Bioburden Monitoring
- Biotech & Biologics Facility EM Programmes
- Sterility Test Area Qualification
- HVAC & Air Handling Unit Monitoring
- Personnel Monitoring (Gloves, Gowns, Surfaces)
Frequently Asked Questions
Q: Why are neutralizers important in environmental monitoring plates?
A: Pharmaceutical cleanrooms use disinfectants (e.g., quaternary ammonium compounds, phenolics, beta-lactam antibiotics, oxidising agents) that can inhibit microbial growth on agar plates, producing false-negative EM results. Neutralizers such as Lecithin, Polysorbate 80, Lactamator, Penase, Histidine, and Sodium Thiosulphate counteract specific disinfectant classes. HPS x CMP SteriPack plates are available with targeted single, dual, or 4-neutralizer combinations to match your cleanroom disinfection programme.
Q: What is the difference between a settle plate and a contact plate?
A: A settle plate (90mm) is left open in a defined cleanroom location for a specified duration (typically 1–4 hours), passively capturing airborne microorganisms that settle under gravity — used for air bioburden monitoring. A contact plate (55mm, convex surface) is pressed directly onto surfaces such as equipment, work benches, or personnel gloves to actively sample surface contamination. Both are required in a comprehensive environmental monitoring programme under EU GMP Annex 1 and ISO 14644.
Q: Do SteriPack plates meet EU GMP Annex 1 and USP/EP requirements?
A: Yes. HPS x CMP SteriPack Triple Wrapped Media are gamma-irradiated and undergo growth promotion testing that meets USP <1116> and EP 5.1.6 requirements. The triple-wrapped sterile packaging is designed for use in ISO 5 / Grade A cleanroom conditions. Each lot is supported by a Certificate of Analysis, which can be provided for GMP documentation purposes.
Get in Touch
📧 Email: info@hiproscientific.com
📞 Call or WhatsApp: +65 8163 3185
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