STERILE DISINFECTANTS
We understand the importance of Pharmaceutical & Healthcare providers to be in line with the current GMP standards & regulations when introducing disinfectants to be used in a critical area/Cleanroom. Annex 1 introduces tighter regulations and fills in gaps with updated regulations to both EU GMP and US FDA when dealing with contamination and residue control solutions.
QuantumTec’s USP Grade disinfectants assists Pharmaceutical manufacturers and Healthcare industry when making tough and important choices.
Daily disinfection/cleaning use
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- IPA 70/30 with WFI
- Denatured Ethanol 70/30 with WFI
Sporicide and rotational use
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- Hydrogen Peroxide 6% with WFI
- Sodium Hypocholorite 0.52% with WFI
Wide area & broad spectrum disinfectant
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- Quaternary Ammonium concentrate.
Residue Removal Detergent
All products comes with either Sterile or Non-Sterile options.
Key feature of QuamtumTec product line up includes:
- Certified ISO manufacturing facility
- Production in line with Good Manufacturing Practices (GMPs)
- Locally manufactured in Malaysia.
- Validated Sterility Assurance Level (SAL = 10-6) for sterile products
- Technical data and Test reports are readily available.
- Ready to use bottles keeps contamination control in check.
- Bag in bottle design. Sterile content remains sterile.
- Certificate of Analysis and Irradiation are included with each batch/lot produced.
- Document availability eases audit proses
ISO Certified facility in manufacturing all QT product range that adheres to strict GMP requirements.
Investment in high tech machineries enables bottles to be filled without human intervention, and based on product/models, they can be either gamma irradiated or asepticlly filled.
Strictly monitored machinery that specializes in different functions are used to produced various types of bottle and cannister options.
Products are always tested by the quality control team to ensure standards are met at all times.
Critical or controlled environments requires high performance wipes, which are now made possible with options such as dry or pre-saturated. Wipes choices can be made using non woven or polyester, depending on industry’s choice and types of surface to be used on.
Product packaging are sealed and double bagged which are suited for use in Grade A or ISO 5 cleanroom environment.
Products are packed using strong industry standard packaging, adhering to labels and crutial information such as expiry, lot numbers are clearly printed on.