Q. What makes a SP PennTech vial washer so efficient?
The objective of vial washing is to remove particulate matter and microorganisms. Traditional vial washers have many moving parts (grippers with springs, penetrating spray needles, chains, and moving rods) in the washing chamber, all of which, generate particulate matter. SP PennTech washers have only two moving parts in their washing chamber and their main drive is servo-driven.
SP PennTech vial washers feature a 15-minute changeover to a different vial format, no penetrating nozzles, and they self-drain after the end of a batch.
Each vial format has an HMI selected “recipe” with specific settings for spray time and indexing time to help reduce water consumption.
Water for injection (WFI) can be recycled, filtered and used a second time, further reducing water consumption. These factors result in a highly efficient vial washing process.
For almost 25 years, SP PennTech has optimized and perfected the art of vial washing. In doing so, their equipment has a very small footprint, making them easy to maintain, changeover, and operate.
Q. What is the typical operating temperature of a SP PennTech sterilization tunnel?
Heat is generated by silicon controlled rectifier (SCR) heating elements. Depending on the format, vials stay inside the sterilizing/depyrogenation chamber for approximately 6-10 minutes. The recirculated hot air is blown at a speed of approximately 0.7 m/s over the vials and remains within 2°C of its setpoint.
The typical operating temperature of the tunnel is 320°C. At this temperature, it takes 9.5 seconds to reduce the bacterial endotoxin level by 1-log. A 4-log reduction will take 38 seconds, and a 6-log reduction in bacterial endotoxin 57 seconds.
Q. What is the net weight filling option for a SP PennTech aseptic filler?
Optionally, load cells can be installed for net weight filling. The vial transport belt places the vials onto the load cells in such a fashion that the vials are free-standing without touching the transport belt.
The settling time of the load cells is 120ms, during which time the filling nozzles dive down for bottom-up filling.
Of the total fill, 90% will be dispensed at “high” speed and 10% at “low” speed. The fill volume and the speed are part of the recipe per vial.
The filling algorithm calculates the cut-off time during the low-speed liquid dispensing, with a repeatability factor of 0.0005 grams. The two load cells function independently from each other.