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If you are doing any sampling, testing, or validation, you need to make sure the results were not skewed by a contaminant that may have come from the container. Newly manufactured bottles and vials may contain release agents and contaminants from the manufacturing factory which coats all surfaces of these bottles or vials on both the inside and outside. Conditions of storage or transportation also have the possibility of adding contaminants as well. To obtain clean containers or clean vials, rigorous mechanical, chemical, or other cleaning procedures must be employed.
All Qorpak pre-cleaned containers are supplied with caps attached. We offer a wide variety of bottle/closure/cleaning service combinations. Please contact us for more information on the combination best suited to your application and for part numbers.
Answer these questions and Qorpak can help guide you to the proper cleaning process for your application.
Absolutely - we provide certification for containers cleaned to Protocol A, B, C, TOC, Super Clean, and Ultraclean. Containers are available Cleaned & Certified or Cleaned only. Certificate of Analysis provides a lot number and stock number and meets or exceeds specifications listed on the certificate. Sample certificates are available to determine if a cleaning process will meet your particular requirements.
There are so many cleaning processes that you must first determine what “pre-cleaned” means to you.
Precleaned is a very broad term. Please use this quick reference as a starting point in determining your needs.
Process removes contaminates such as loose dirt, dust, carton lint and fine glass particles:
Applications
Features & Benefits
Process removes same contaminants as Vacuum & Ionization plus any particles that are adhering to the package that cannot be blown out with air.
These products are used for environmental sampling applications and are tested for specific elements or analytes. KaptClean® glass containers are typically capped with polypropylene caps with PTFE disc liners or hole caps with septa. KaptClean® plastic containers are typically capped with polypropylene caps with F217 discs.
Ready to Clean bottles are designed for users who prefer to use their own cleaning process. Ready to Clean bottles are fully assembled with polypropylene caps and PTFE disc. Both cap and liner can be washed, heated or autoclaved (glass only) depending upon your application. The PTFE disc is chemically inert, and will not interfere with your test results.
Containers are cleaned based on OSWER directive from the EPA. Certifications are completed at an independent laboratory. Analytes that are commonly analyzed:
Vials and containers with septa caps are most commonly cleaned for volatiles. Containers are cleaned based on OSWER directive from the EPA. Certifications are completed at an independent laboratory. Analytes that are commonly analyzed:
Containers are cleaned based on OSWER directive from the EPA. Analytes that are commonly analyzed:
TOC is the total amount of organic carbon present in a sample. Certified to contain less than 20µg/L, or 10µg/L (same as ppb)
PLEASE NOTE: Containers are designed only for general laboratory and industrial fluid sampling applications where particulate cleanliness of the container is required. Containers are not designed for use in pharmaceutical, medical device, chemical packaging, or manufacturing applications due to consideration of other requirements that may affect their suitability for use. For cleaned containers for pharmaceutical, medical device, chemical packaging, or manufacturing applications, or for containers that require a certification of analysis or adherence to cGMP quality requirements, please inquire about our custom cleaned containers.
Pyrogens are fever causing contaminants and may include bacteria, even bits of dead bacteria. The Pyrogenicity test is called Limulus Amoebocyte Lysate (LAL) Test. Pyrogens can be difficult to remove and can be insensitive to pH changes. There are several processes to depyrogenate a container.
DNase and RNase are nucleases that degrade nucleic acids; therefore sample containers that are free of RNase and DNase are essential for some methods.
DNase degrades DNA and its presence is a threat to many molecular biology experiments. Common sources of DNase are found in human contact, saliva and bacteria from non-sterile environments. Sometimes talking is all that is needed to contaminate a product. DNase Free containers are important in the gene therapy, pharmaceutical, chemical, molecular and diagnostics industries.
RNase frequently contaminates common molecular biological reagents such as reaction buffers, enzymes such as reverse transcriptase, RNA polymerase, and buffers for RNA purification and storage. Accidental RNase contamination is commonly from oils from hands, face, arms, hair, and bacteria from non-sterile environments. RNase is very durable and can be difficult to remove completely. Pharmaceutical and diagnostic firms, research institutions that deal with gene therapy are common industries where RNase issues are critical.
Silanization is mostly utilized for glass vials and deters interaction between biological compounds and the glass. This process inhibits materials from adhering to the surface of the container, allowing for maximum recovery of the contents.
A methysilylating agent is introduced by vapor phase deposition onto the surface of the disposable glassware. The silylating agent reacts with active groups on the surface of the glass effectively tying up these sites so they are less reactive. This treatment inhibits materials from adhering onto the surface of the container, allowing for maximum recovery of trace analyte. This can help to keep the glass clean over several washes and help to prevent materials from sticking to the glass. Typical applications include proteins, assays of blood serum and pharmacological assays of therapeutic drugs.
The degree and type of sterilization required should be determined by the kind of product to be sterilized.
Gamma Irradiation — This process can turn clear glass light amber and plastics yellow. You must determine specified radiation dose and testing is available to determine exposure levels needed.
Ethylene Oxide Gas — This gas sterilization process disrupts the DNA of microorganisms, which prevents them from reproducing and consists of four primary variables: gas concentration, humidity, temperature, and time.
Electron Beam — This beam inactivates microorganisms either by causing microbial death as a direct effect of the destruction of a vital molecule or by an indirect chemical reaction. This is the same mechanism as in gamma irradiation, and the dose required is the same.
This sterilization process is typically done in the lab for equipment and supplies. The autoclaving process works by the concept that the boiling point of water (or steam) increases when it is under pressure. Items to be autoclaved are subjected to gradual temperature increases under high pressure until 121 °C is reached and then steamed for around 15–20 minutes. Items should be separated to allow the steam to penetrate the load evenly. The steam can reach in small crevices and can kill all bacteria, viruses and bacterial spores.
Closures should be autoclaved separately or very loosely on top of container; otherwise a vacuum is created during cooling. Liners will get sucked into the container or bottles and caps can crack or warp. Expanding vapors during heating can also cause containers to crack or explode without sufficient ventilation.
Because autoclaving sterilizes without the use of reagents and allows for the re-use of lab equipment and supplies, it is environmentally friendly. Autoclaving can also be used to sterilize medical waste prior to disposal instead of incinerators.
Not all materials are safe for autoclaving and then re-use in the lab. Some autoclavable Qorpak products include:
The Vacuum and Ionization process removes contaminants such as loose dirt, carton lint, aerosols, and fine glass particles.
Benefits of V & I:
Qorpak has the experience to help guide you through the process of selecting a cleaning process and container to match your application and avoid costly contamination of your results. We can also work with you to develop a proprietary cleaning process to fit your specialized application. Call us for a free consultation at 1.800.922.7558.