At Azenta Life Sciences, we know how important it is to provide labware in pristine condition and suited for your research. This is why we provide four alternative methods for contamination-free products.
1. Standard Products
Prevention is better than a cure, so we manufacture all sample storage consumables in an ISO class 8 clean-room environment. To gain access to this area, everyone must wear a gown, gloves, face mask, hair net and overshoes. In addition, they must pass through a double door with an "air-shower" designed to remove any particles. No material that could cause contamination is allowed in the clean-room.
The products are sterile at the point of molding, which takes place at temperatures that melt the resin – typically between 140°C to 150°C for copolymer and 165°C to 175°C for homopolymer.
From the injection molding machine, our consumables are processed and bagged in the clean-room. Only once they have left the clean-room are they are placed in the transport box for shipment.
The efficacy of this process is tested periodically, which allows us to have a high degree of confidence that our products meet the standards outlined in the table below.
|Endotoxin (Pyrogen)||Product(s) are tested on a periodic basis and found to be below the acceptance level ≤ 0.05 EU/ml|
|DNA / RNA
|Product(s) are free of contaminations based on third-party electrophoresis evaluation of degradation|
|Heavy Metals||No heavy metal is contained in any of our product(s) that meet CONEG requirements of 100 ppm/weight|
|PCR Inhibitors||Product(s) are PCR-inhibitor free|
2. Gamma Irradiation Sterilization
Typically, laboratory consumables requiring sterilization are treated to ensure a "Sterility Assurance Level" (or SAL) of either 10-3 or 10-6. Irradiation does not guarantee the product is free from other contaminants such as those listed above, only that there are no viable micro-organisms. It is still essential to confirm no contaminants are present to verify SAL.
Gamma irradiation is not guaranteed to destroy DNA contamination to the point where it doesn't amplify or interfere with subsequent analysis. Ensuring that no amplifiable DNA is present relies on (i) the manufacturing process and testing described above and (ii) fulfilling requirements for sensitive applications such as sterilization using Ethylene Oxide (EtO).
Gamma irradiation can negatively affect polypropylene, making it more brittle over time and increasing the binding characteristics of the plastic. For this reason, Azenta Life Sciences recommends that wherever possible, standard product is relied on to deliver the contamination-free consumables required for research and long-term storage.
3. Ethylene Oxide Sterilization (EtO)
Sterilization using EtO is just as effective as gamma irradiation at providing a sterility assurance level of 10-6. In addition, it ensures there is no DNA that can be amplified to a level where there is risk of subsequent interference. Therefore, EtO is the sterilization method of choice in critical areas such as forensics.
4. Dual Ethylene Oxide Sterilization (EtO)
The newly published ISO 18385:2016 standard centers on minimizing the risk of human DNA contamination in consumable products used in collection, storage, or analysis of biological material for forensic DNA purposes. Dual EtO treatment is being recommended to further minimize the presence of PCR-amplifiable DNA.
|Standard product||Gamma irradiation||Ethylene oxide||Dual ethylene oxide|
|General description||Product is made in an ISO 8 (class 100K) clean room. Product is endotoxin (pyrogen), DNA/RNA, heavy metals & animal-free.||Ensures no viable micro-organisms but cannot guarantee destroyed DNA contamination. Affects PP, making it more brittle over time & increasing binding of plastic.||Effective at ensuring no DNA can be amplified to a level where there is any risk of interference.||Recommended for consumables used in the collection, storage, or analysis of biological material for forensic DNA.|
|Recommended for standard use||Yes||No||No||No|
|Recommended for critical forensic applications (DNA amplification)||No||No||Yes||Yes|
|Product types||All||Pre-capped or uncapped tubes||Uncapped tubes only, bulk caps, cap carriers||Uncapped tubes only, bulk caps, cap carriers|
|Packaging||Bulk / case of 10 racks||Sleeve of five racks as standard – individually wrapped as option||Individually wrapped||Individually wrapped|
|Minimum Quantity||None||10 cases||25 cases||25 cases|
|Example Part Number||