Do you need a Referee Level Particle Standard Set quickly?
The normal lead time for a Referee Level Particle Standard set is 8 – 10 weeks after the receipt of customer supplied materials. The largest percentage of time required for the manufacture of a RLPS™ set is cleaning the containers properly. This cleaning phase can take 6 – 8 weeks and is really dependent on the quality of the glass provided. As an alternative Phoenix Imaging Ltd. has developed a series of RLPS™ sets that can be delivered within two weeks of order based on common size containers that have been pre-cleaned. The cleaning procedure still takes 8 – 10 weeks to complete but this is performed before the customer places the order for an RLPS™ set.
The process time for a “Rapid-Delivery Set” (aka RDS) is the time required for seeding, labeling, inspecting and documenting the containers. The total time for delivery of an RDS is usually 10 working days or less from receipt of order. We have pre-cleaned hundreds of 1 ml, 3 ml, 5 ml and 10 ml glass vials (Type-I) containers for use in RDS orders, call to check for product availability. The vials are filled with WFI to the customer specified fill volume. The vials can use customer supplier stoppers and closures or Phoenix Imaging supplied components, all closures will be laser marked with a unique batch/serial number in both human readable and 2-D code formats. The 2-D codes can be read with most hand-held bar code scanners with 2-D code capability.
What is involved in the selection of a RDS?
The vial size for the challenge set should be similar to the product size being inspected. The particle size distribution is selected based on the size of the container and the light intensity that will be used in the inspection volume. The small the container and the more intense the inspection system lighting the smaller the diameter of the particle distribution.
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Typical vial sizes of RDS containers:
3 ml – 7 mm ID, 13 mm finish, 16.13 mm OD, 32 mm Height
5 ml – 13 mm ID, 20 mm finish, 22.25 mm OD, 39.5 mm Height
10 ml – 13mm ID, 20 mm finish, 24 mm OD, 50 mm Height
The vials are cleaned to the point that no turbidity is detected in the last rinse cycle, then they are filled to just below the finish and stoppered. They will rest in the wait-state until a customer request for RDS is submitted. When selected for use, the technician will select the seed material, measure the seed material for accurate size, photograph the seed, transfer the seed to the container, inspect the container to verify presence of a single seed, and then seal the container with a laser marked closure. This process is repeated for required number of seeded container ordered. The “Clear” or unseeded vials start with a similar process but are inspected to insure that the WFI is free of contamination. All inspections are performed using 10,000 ft.-cd illumination and will provide detection of particles as small as 2µm in size. If any contamination is detected, the vial is rejected and recycled.