Single Use Process Components Normally are Required to Pass USP Class VI Testing
To begin, let us explain first what USP actually stands for: The United States Pharmacopeia (USP) is a non-government organization that endorses public health by establishing up to the minute standards to safeguard the quality of medicines and other health care technologies. This organization is concerned with the pharmaceutical and bio-technology industries. The USP sets standards for quality, purity, strength and consistency. These USP Standards are published in the US Pharmacopeia and the National Formulary (USP NF).USP Class IV types of products go through a series of biological tests. The USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tight requirements for leachates.
Animals are used to test the toxicity of materials.
- Acute Systemic Toxicity Test: This test measures the irritant effect of the test material and governs its human hazard potential. Toxicity is determined by oral, dermal and inhalation.
- Intracutaneous Test: This specific test administers the material straight to the tissues it will be in contact during normal use without protection of the skin or any other body system. This will allow the testing team to assess the response of particular tissues to the material.
Implantation Test: Sqlpro for sqlite 1 0 50 – advanced sql editor. The implantation test determines the response of live tissue to the material when implanted into a live animal. The standard implantation time required for a USP Class VI test is five days. If after the five-day period there are no signs of irritation or toxicity, it will meet the implantation requirements of the test.
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- Standard Temperatures and Times: The material extracts used on the systemic toxicity and intracutaneous tests are fixed at set temperatures and exposure times to ensure the results meet a common standard. All material extracts are processed using three different temperature and time exposure conditions. Initially it is administered at 122 degrees Fahrenheit, or 50 centigrade, during 72 hours, then at 158 Fahrenheit for 24 hours and finally at 250 Fahrenheit one hour.
USP Class VI Plastic Tests are designed to evaluate the biological reactivity of various types of plastics materials in vivo. Developed to test drug containers, the class plastics tests are frequently done on unmolded plastic resins as well as containers. Class plastics testing is not a replacement for biocompatibility testing, but is commonly used by manufacturers to classify materials.
There are three in vivo tests included in the classification of plastics. The Systemic Injection Test and the Intracutaneous Test are designed to control the systemic and local biological responses to plastics and other polymers by the single-dose injection of specific extracts made from a sample. The third test, the Implantation Test, is designed to assess the reaction of living tissue to a test material. The testing for the six different class plastics levels is all done using different arrangements of these three tests and different extracts.
The USP defines six plastics classes, from I to VI (VI remaining the strictest). Consequently, several plastics manufacturers find it beneficial to have their plastic resins certified as USP Class VI, particularly if the resin is a candidate to be used in medical devices. A plastic resin material that has passed Class VI certification is expected to be more likely to produce favorable biocompatibility results.
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For a product to pass USP Class VI standards, it must exhibit a very low level of toxicity by passing all of the tests requirements. Compliance to USP Class VI is often requested by end users. Testing for compliance involves an assessment of the effects of the material, and extractables, on tissue.
So who uses UPS Class VI elastomers in the sanitary process industry? Primarily biopharmaceutical manufacturers for their process equipment. Sanitary diaphragm valves have USP Class VI diaphragms. Most single use process components such as silicone and C Flex tubing, plastic connectors and single use bags all require USP Class VI certification. Sanitary pumps require Class VI O-rings and seal material. And sanitary Tri-Clamp gaskets are all required to be USP Class VI. Holland Applied Technologies distributes a variety of USP Class VI compliant sanitary hose assemblies, O-rings, sanitary gaskets and seals in various elastomer types, including EPDM, SILICONE, FKM (VITON), and PTFE (TEFLON).
If you have questions about this post or we can be of any assistance to you regarding USP Class VI materials or any other issues in the hygienic process world, contact us and we will do our best to assist you.
These docs are for Rancher 1.6, if you are looking for Rancher 2.x docs, see here.
Rancher NFS
Rancher provides the ability to select NFS volumes as a storage option for containers.
Prerequisites when using NFS
A NFS server has to be installed prior to launching the Rancher NFS driver. For example, to install a NFS server on Ubuntu 16.04, you can use the following commands.
On the server, you will need to export a base directory. First, you’ll need to create the shared directory.
Modify the exports file (
/etc/exports
).Clear V1 1 6 1
After all the modifications, restart the NFS kernel server.
Using the Rancher NFS driver on Amazon EFS
The Rancher NFS driver can connect to Amazon EFS. When using Rancher NFS driver with Amazon EFS, all hosts in the environment will need to be EC2 instances, deployed in the same availability zone as where EFS is deployed.
Setting up Rancher NFS
When setting up an environment template, you can select the Rancher NFS catalog item so that it will be available in any environment created from that environment template.
Alternatively, if you already have an environment set up, you can select and launch Rancher NFS from the catalog. Photo cutter.
Note: Some storage services may not be compatible with some container orchestration types (i.e. Kubernetes). Environment templates will restrict which ones are compatible based on orchestration, but all options are available from the catalog.
In order to launch Rancher NFS, you will need to specify the following:
- NFS Server: NFS server ip address or hostname.
- Export Base Directory: Exported shared directory on the NFS server.
- NFS Version: The NFS version to use, current used version is 4.
- Mount Options: Comma delimited list of default mount options, for example: ‘proto=udp’. Do not specify
nfsvers
option, it will be ignored. - On Remove: On removal of Rancher NFS volume, should the underlying data be retained or purged. Options are
purge
andretain
, default ispurge
. Available as of Rancher v1.6.6.
Rancher NFS Driver Options
When creating volumes using the Rancher NFS driver, there are several options that can be used to customize the volume. These options are key value pairs that can be added in the UI as a driver options or in compose files under the
driver_opts
key.Driver Options
- Host - (
host
): NFS host - Export - (
export
): When the volume is configured with the host and export, no subfolder is created; the root export directory is mounted. - Export Base - (
exportBase
): By default, the volume can be configured with the host and export base, which creates a uniquely named subfolder on the NFS server. - Mount Options - (
mntOptions
): Comma delimited list of default mount options. - On Remove - (
onRemove
): On removal of Rancher NFS volume, should the underlying data be retained or purged. Options arepurge
andretain
, default ispurge
. Available as of Rancher v1.6.6.
Using Rancher NFS in the UI
Creating Volumes
After Rancher NFS is launched in Rancher, you will need to create the volumes in the NFS in Infrastructure -> Storage before using the volume in a service.
- Click on Add Volume.
- Create the name of the volume that will be used in the service.
- Optional: Add any additional driver options.
Using Volumes in Services
Once a volume is created in the UI, services can start using the shared storage. when creating a service, in the Volumes tab, provide a volume and a volume driver.
The volume will be in the same syntax as Docker,
<volume_name>:</path/in/container>
. Docker volumes default to mount in read-write mode, but you can set it to be mounted read-only by adding the :ro
at the end of the volume.The volume driver will be the name of the storage driver, which is the name of the stack. By default, the Rancher NFS storage driver will be
rancher-nfs
.Using Rancher NFS in a Compose File
After the Rancher NFS infrastructure stack has been launched, you can start creating volumes in a compose file.
Volumes can be specified as part of a compose file under the
volumes
key. Each volume can be associated with one or more services in the same file.Note: This functionality is only available when using a compose file in v2 format.
Example of a NFS volume
In this example, we are creating a NFS volume while creating services that use this volume. All services in this stack will share the same volume.
Examples of using host, exportBase and export
The following example shows how to override
host
and exportBase
for this particular service.You can also use a different
exportBase
per volume, see the example below.Using Rancher NFS with AWS EFS
After creating an EFS file system on AWS, you can launch the Rancher NFS driver to use this EFS file system. Since Amazon EFS is only reachable internally, only EC2 instances in the same availability zone can reach this EFS, therefore EC2 instances should be added to Rancher prior to creating the storage driver.
You can launch Rancher NFS with the following options for example:
- NFS Server:
xxxxxxx.efs.us-west-2.amazonaws.com
- Export Base Directory:
/
- NFS Version:
nfsvers=4
Preserving data on volume removal
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The default value for the
onRemove
driver option is purge
. This means that the underlying data will be removed if the volume is removed from Rancher. If you want to retain the underlying data, you can specify the retain
value. You can also override this behavior on a per-volume basis. If the nfs-driver option onRemove
is set to retain
, but you want to purge the data of a particular volume when it’s removed from Rancher, you can configure onRemove: purge
in the driver_opts
of the volume specification inside docker-compose.yml
like in the example below.If the nfs-driver option
onRemove
is set to purge
, you can configure onRemove: retain
in the driver_opts
of the volume specification to preserve the data after the volume is removed in Rancher.Note: Creating an external volume with the same name as a previously removed volume with retained data will make the retained data accessible to the container using this volume.