• Installation Qualification (IQ) assures you that your system is received in good condition and as ordered. It will verify that the system meets specifications. It will also certify that the system is set up and installed correctly, in the right environment, and ready for further operational qualifications and performance qualifications.

Dedicated to Meeting Your Needs

• Operational Qualification (OQ) verifies that the system is functioning and that all critical operational parameters are within specifications. This certifies that the mechanical performance of the system is satisfactory and that the system is available for further performance qualification.

• Performance Qualification (PQ) will be performed to ensure that the system is working properly. It will verify and certify that the instrument meets system suitability test requirements per USP guidelines using USP calibrator tablets.

• Preventative Maintenance (PM) is performed to assure that the system continues to operate properly and no component of the system becomes incompatible due to wear and use. Includes inspection and servicing of equipment to ensure continued proper operation per the manufacturer’s specifications. Parts and components requiring replacement will be replaced. All electronic and mechanical components will be inspected and replaced as necessary. Connections, switches, motors, and the like will be inspected and activated to verify proper performance.

• Operational Qualification/ Performance Verification (OQ/PV) is performed to make certain that your UV-Vis Spectrophotometer performs within specified requirements and supplies the evidence needed to meet the requirements of regulatory agencies. Distek is also pleased to offer validation contracts to help you eliminate worry while keeping costs down. Quantity discounts are available. Call for details.

Validation Services Much like our philosophy for designing quality instrumentation, Distek’s Validation Services Group utilizes highly skilled chemists and technicians dedicated to meeting your needs with an unparalleled commitment to customer satisfaction. Our product is our people. Each validation service professional undergoes comprehensive training and certification in all aspects of validation service to assure you that your instrument is performing according to specifications. All measuring tools used are calibrated and traceable to NIST standards and at the conclusion of your service, Distek will provide you with comprehensive documentation for each instrument that meets the requirements of cGMP, GLP, and other quality standards. Distek is committed to providing you with the consistent, traceable results needed to satisfy your regulatory requirements, thus instilling confidence in the integrity of the results and eliminating the risk of financial loss caused by non-compliance. We save you valuable time and money, by eliminating the need to write your own SOP’s to qualify your instruments as well as the need to train your staff to execute them. Our Validation Services Group offers products and services in the areas of installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and preventative maintenance (PM) both on a one time and annual service contract basis. Please contact Distek’s Validation Services Group at 1-888-2-DISTEK for more details.

Distek Validation Tools All Distek Validation Tools come ready to use with NIST traceable calibration certificates. • CenterChek The CenterChek allows users of all dissolution test systems to accurately verify paddle or basket shaft centering closer to the dosage form inside the vessel.

• HeightChek The HeightChek is a novel gauge that can accurately set the paddle or basket height prior to a test, or it can be used as a precision tool to validate the height of each stirring element.

• ShaftChek The ShaftChek is a calibrated NIST traceable precision measurement device for checking and straightening paddle and basket shafts. Additionally, distorted baskets can be re-shaped and paddle blades can be verified for adherence to USP specifications.

• Tachometers Distek offers two tachometers to verify rotations per minute: a contact tachometer which features an easy-to-hold curved design with a measurement range of 1.5–10,000 rpm and an optical tachometer which utilizes visible red light and has a measurement range of 30–50,000 rpm.

• TempChek The TempChek’s high resolution (0.01°C), accuracy (±0.02°C) and portability make this precision instrument useful for dissolution vessel and general-purpose temperature measurements or as a NIST traceable reference thermometer.

• WobbleMeter The WobbleMeter features a light and versatile design, effective with all vessel positions on any dissolution apparatus. Additionally, the base of this measurement device can be easily attached to the vessel plate with the use of a common C-clamp, insuring faster setup and improved accuracy.

• Additional Tools VesselChek Used to verify the conformity of a vessel.

0500-0299

VibraChek Used to validate benchtop vibration.

0500-0319

• Kits Kit #1 — Includes CenterChek, HeightChek, Wobblemeter and Contact Tachometer

0505-0001

Kit #2 — Includes CenterChek, HeightChek, Wobblemeter and Optical Tachometer

0505-0602

• Distek also offers recalibration service for all of our validation tools Recalibration of CenterChek, HeightChek, ShaftChek, Tachometer, VesselChek, or WobbleMeter

0010-0601

Recalibration of Tachometer with additional calibration point (6 points total)

0010-0602

Recalibration of TempChek

8100-0323

Recalibration of TempChek with additional calibration point (3 points total)

8100-0324

Recalibration of VibraChek

8100-0320

888.2.DISTEK 888.234.7835

[email protected] www.distekinc.com

121 North Center Drive • North Brunswick, NJ 08902

QFRM-5029 Rev. A