NEWS
Lyophilization Cycle Development Equipment In Place
September 2009: UIP has completed installation of a Lyotherm 2 and Lyostat 2 from Biopharma Technology Limited. The Lyotherm 2 provides integrated Differential Thermal Analyser (DTA) and electrical impedance (Zsinφ) capability in a single instrument. The Lyotherm 2 is designed to measure glass transition (Tg'), eutectic (Teu) and melting (Tm) temperatures relevant to freeze-drying formulations. The Lyostat 2 is a fully integrated freeze-drying microscope that enables critical events such as collapse and melting to be observed in situ, as well as characteristics such as skin or crust formation to be observed and identified. The coupled Lyostat 2 and Lyotherm 2 units provide valuable information for both formulation and cycle development processes. With UIP's in-house expertise in lyophilization, the purchase of this system will allow quicker and more efficient development of lyophilization cycles. In fact, already during installation testing and training, UIPDC staff were able to discover a potential solution to a lyophilization challenge presented by a research project.
For a limited time UIP is offering FREE lyophilization cycle development.*
*Through credit on subsequent batches produced at UIP.
New Sterile Fill Line
August 2009: UIP has completed qualification of a new Flexicon FP50 Aseptic Filling and Stoppering Machine for use in the Clean Room that serves our Hull 48 square foot lyophilizer in the Sterile Products department. The FP50 is designed to operate at speeds of up to 25 vials per minute, filling from 0.5 to 50 mL per vial with a filling accuracy of better than ± 1% (depending on the fill volume). The entire fluid path of the peristaltic filling system is single use silastic tubing. Self standing glass vials from 2 mL to 50 mL can be filled and stoppered with 13 mm or 20 mm stoppers. The filling and stoppering operations take place within the ISO Class 5 (Class 100) areas in the Sterile Products Clean Rooms in accordance with both FDA and EU regulatory requirements.
Facility Expansion
July 2009: Renovation of an additional approximately 1,000 square feet of newly acquired space in UIP’ building at the Oakdale Research Park nears completion. This space will allow UIP to consolidate all of its analytical operations in one location. This will increase the flexibility of staff and analytical equipment, enhancing the efficiency of UIP' analytical method development and validation and Quality Control testing services. UIP expects the relocation of personnel into this space to be completed by late summer to early fall. Use of the vacated space at the UIP College of Pharmacy location for other functions will allow for improved personnel and material flows within this facility. Relocations will be accomplished without impact ongoing analytical or manufacturing operations.
Approvable Recommendation
June-July 2009: In a letter dated June 15th from the Kansas City District Office of the FDA, UIP received notice that based on the results of our most recent GMP inspection (March and April of 2009) the Kansas City District has recommended that a client’s ANDA is approvable. In a separate communication dated July 2nd from the Kansas City District Office of the FDA, UIP received the establishment inspection report (EIR) for our most recent GMP inspection, indicating that the FDA has closed this inspection and found UIP’ responses to the auditor’s findings acceptable.
Minncare DRY FOG SYSTEM
June 2009: UIP purchased a Minncare Dry Fog System which is currently being qualified for use in the Sterile Products department. The Dry Fog system provides an easy to use process for Clean Room fogging. The combination of cold sterilant and state of the art Dry Fog delivery system enables a rapid and safe delivery of sanitizing solution vapor to even the most hard to reach areas of our Clean Rooms. The Dry Fog equipment produces fine droplets which ensure even dispersion of disinfectant solution throughout a room. These small droplets tend to bounce off solid surfaces, avoiding excessive condensation, corrosion and surface wetting issues. The small droplets penetrate normally inaccessible areas and lead to a more effective sanitization process. The cold sterilant is a peracetic acid and hydrogen peroxide based chemical registered with the EPA for use as a fog to enhance existing cleaning and disinfection processes. It is fully biodegradable and will leave no measurable air residuals once the room has been fully ventilated. The use of this unit will provide an added level of assurance that UIP Clean Rooms have been effectively cleaned for aseptic operations.
Lyophilization Cycle Development Equipment Ordered
May 2009: UIP issued a purchase order for
a Lyotherm 2 and Lyostat 2 from Biopharma Technology Limited. The Lyotherm 2 provides integrated Differential Thermal Analyser (DTA) and electrical impedance (Zsinφ) capability in a single instrument. The Lyotherm 2 is designed to measure glass transition (Tg'), eutectic (Teu) and melting (Tm) temperatures relevant to freeze-drying formulations. The Lyostat 2 is a fully integrated freeze-drying microscope that enables critical events such as collapse and melting
to be observed in situ, as well as characteristics such as skin or crust formation to be observed and identified. The coupled Lyostat 2 and Lyotherm 2 units provide valuable information for both formulation and cycle development processes. With UIP's in-house expertise in lyophilization the purchase of this system will allow quicker and more efficient development of lyophilization cycles.
CLEAN ROOM OPERATOR TRAINING
February 2009: Anne Marie Dixon, the managing partner of Cleanroom Management Associates, Inc., conducted a 3 day intensive Clean Room operator workshop on site. Ms. Dixon has been actively engaged in the field of Contamination Control since 1976 with extensive experience in the areas of training, strategic consulting and technical writing. Ms. Dixon has trained over 250,000 cleanroom technicians and managers. She is the author of over 90 technical papers and 5 books. UIP is excited to have had the opportunity to have Ms. Dixon in to conduct this training.
New Sterile Fill Line
January 2009: UIP issued a purchase order for a second new Flexicon FP50 Aseptic Filling and Stoppering Machine for use in the Sterile Products department. The FP50 is designed to operate at speeds of up to 25 vials per minute, filling from 0.5 to 50 mL per vial with a filling accuracy of better than ± 1% (depending on the fill volume). The entire fluid path of the peristaltic filling system is single use silastic tubing. Self standing glass vials from 2 mL to 50 mL can be filled and stoppered with 13 mm or 20 mm stoppers. The filling and stoppering operations take place within the ISO Class 5 (Class 100) areas in the Sterile Products Clean Rooms in accordance with both FDA and EU regulatory requirements.
The University of Iowa Pharmaceuticals Development Consortium
January 2009: The University of Iowa Pharmaceuticals Development Consortium (UIPDC) will be officially launched. This organization consists of the University of Iowa College of Pharmacy pharmaceutics faculty and The University of Iowa Pharmaceuticals personnel. This new group will be focused on preformulation, technical feasibility and formulation development projects especially for compounds that present scientific challenges (solubility, stability, polymorphism, etc.). The technical expertise of the pharmaceutics faculty will be utilized in combination with the client-focused management and manufacturing skills of UIP staff to expand pharmaceutical development capabilities at the University of Iowa.
New VIAL WASHER
December 2008: UIP completed the qualification and validation of a new Steriline model RA-AV2 Vial Washer within the Sterile Products department. The Steriline Washer has been validated to clean vials with both 13 mm and 20 mm openings, ranging in size from 2 mL up to 100 mL. Each programmed washing cycle consists of alternating spraying’s of Water for Injection and compressed air, to provide a more effective cleaning process. Both internal and external spraying of Water for Injection and compressed air are performed. The rotary washer utilizes lifting needles for a more thorough internal washing of each container. The control system and audit trail are 21 CFR Part 11 compliant.
Flood
June 2008: There was significant flooding in the Iowa City area as well as much of Iowa. Fortunately, UIP’s operations were not impacted. The main facility is on a bluff high above the river bottom and was in no danger of flooding. The facility at the University of Iowa Research Park is on high ground far from the river. Staff levels at the main facility were reduced to a minimum during the week of the worst flooding due to flood waters covering many of the local and arterial roadways in and around town, and much of the available parking space. The reduced staff levels allowed staff to assist in sandbagging efforts. As a precaution, all production and analytical activities scheduled for this particular week at the main facility were rescheduled in case a loss of power was to occur. Fortunately, power was maintained to the facility throughout the crisis. Backup power generation capacity was on standby to keep all essential systems operating (such as stability chambers).
http://maps.facilities.uiowa.edu/website/campusaerialphotosflood/viewer.htm
New Sterile Fill Line
May 2008: UIP completed the qualification and validation of a new Flexicon FPC50 Aseptic Filling, Stoppering and Crimping Machine in the Sterile Products department. The FPC50 is designed to operate at speeds of up to 25 vials per minute, filling from 0.5 to 50 mL per vial with a filling accuracy of better than ± 1% (depending on the fill volume). The entire fluid path of the peristaltic filling system is single use silastic tubing. Self standing glass vials from 2 mL to 50 mL can be filled, utilizing 13 mm or 20 mm stoppers and flip-off crimp seals. The filling, stoppering and crimp sealingoperations all take place within the ISO Class 5 (Class 100) areas in the Sterile Products Clean Rooms in accordance with both FDA and EU regulatory requirements.
Merger
March 2008: The University of Iowa, College of Pharmacy Division of Pharmaceutical Service and Center for Advanced Drug Development merged to form The University of Iowa Pharmaceuticals. This merger was undertaken to streamline our operation and capitalize on the strengths of both functional areas. All personnel and facilities were retained, with the former director of the Center for Advanced Drug Development, S. Alta Botha, D.Sc., assuming the position of scientific director and Mickey L. Wells, Ph.D. becoming the overall director of the combined organization.
New Fluid Bed
February 2008: UIP purchased a Vector Lab-1 fluid bed processing unit for use in the Solid Dosage Forms Department. This unit has the capability to perform top spray granulation and Wurster coating
operations. While not purchased with rotor capability, this feature can be added if needed. This unit has been fully validated and has already been used to process a number of batches of product. UIP personnel have extensive fluid bed experience working with other fluid beds from both Glatt Air Techniques and Vector. The purchased unit complements our existing Vector Mini Fluid Bed.