Calibration Protocols Accuracy Tests Only Appropriate for companies that have approved validation procedures Basic documentation for maintenance and calibration Equipment Validation As mentioned earlier, each piece of must be validated in order to legally operate within the facility. TEMPERATURE Range 30 - 50 o C Accuracy + 1 o C Temp. The goal is to produce consistent results with minimal variation without compromising the integrity of the product and the persons operating the equipment. Control Microprocessor Based using PT100/Semiconductor Sensor SAMPLING Reaction Vessel 1000 ml jars with stirrer pedals and baskets Heater 1 KW Power 230 V ± 10%, 50 Hz.
Guidelines for validation are set by the FDA, but the specifications of validation are determined by the pharmaceutical/biotech company. Validation is broken down into 5 main phases, Design qualification (DQ ). Calibration is performed using primary reference standard. A true calibration usually contains both "as found" and "as left" data. Facility for 20 different test setups available in Routine and Sustain mode. in Model - 1916) Glass pipettes with rubber bellows Mains Lead Instruction Manual Dust Cover Friability Apparatus.
A validation is a detailed process of confirming that the instrument is installed correctly, that it is operating effectively, and that it is performing without error. 19 mm (3/4") Punch Length 133.65 mm (5.262") Operating Force 6.5 Tons Max . AC Dimensions 450 mm (H) X 300 mm (W) X 320 mm (L) (Approx.) Weight 8 Kgs . GENERAL Stations 8 Stations in Model - 1918 6 Stations in Model - 1916 Display 20 x 4 Line Alphanumeric LCD display with Backlit Keyboard 19 soft touch membrane keys LED' 6 LED's, 3 LED's for Test status like Run, Alarm, End and 2 LED's for Platform up/down status and one for heater ON/OFF status. Printer Provision for the attachment of dot-matrix printer with centronics parallel port interface available. Display 3 digit bright red seven segment LED display Accuracy ± 1 revolution Resolution 1 revolution Range 0-999 revolutions No.
Because a validation must test all three of these operational parameters, it is broken into three different tests: the installation qualification (IQ), the operational qualification (OQ), and the performance qualification (PQ). QUALIFICATION CALIBRATION Qualification Workbooks(IQ, OQ, PQ) & Project Diskettes Accuracy, Linearity and Precision Tests Appropriate for companies without approved qualification procedures Meets or exceeds US FDA qualification requirements. Depth of Fill 17.4 mm Electric Motor 3 HP/ 1440 RPM 440 V/ 50CS/ 3PH. PACKAGING SPECIFICATIONS Particulars Unit STD GMP Machine Dimension Inch L x W x H 39 x 39 x 70 L x W x H 39 x 39 x 70 Case Dimension Inch L x W x H 50 x 53 x 72 L x W x H 57 x 54 x 83 Net Weight Kg . 3.5 4.5 Case Volume M3 3.5 4.5Disintegration Apparatus Model 901 System Digital Tablet Disintegration Apparatus Up and Down Speed 30 rpm ± 2 rpm Accuracy 2% Resolution 1 sec. STIRRER Speed 25 - 200 RPM, + 1 RPM Resolution 1 RPM Accuracy + 1 RPMDissolution Apparatus.
Food and Drug Administration (FDA) This section will explain the role of the FDA in validation and the guidelines it sets forth. Vendor ’ s Site Owner ’ s site Before Purchase Before Use After Use Structurally Validated Products DQ Functional Validation Installation Operational Performance Qualification Qualification Qualification Maintenance OQ PQ IQ OQ PQ System Suitability During Use Validation vs. Validation: Refers to the total life cycle of a product from development through use and maintenance. WEIGHING CAPACITY 42/210 gm READIBILITY 0.00001gm/0.0001 gm REPEATABILITY 0.00002/0.0001 gm LINERITY ± 0.00003/0.0002 gm STABILISATION TIME 3.5/8 Sec TARING RANGE SUBSTRACTIVE 210 gm CALIBRATION Internal OPERATING TEMPERATURE RANGE 5˚ C to 40˚ C, 85% RH or less WEIGHING UNIT pcs , gm , mg, oz.
This section will define validation and will put its meaning in terms pertinent for a technical person. This section will define calibration and will put its meaning in terms pertinent for a technical person.
Equipment Validation This section will explain what role unit operations equipment plays in validation and why that is important What is Validation? Owners are responsible for Validating Their Processes (personnel, equipment, methods, SOPs) to ensure compliance to c GMP /GLP regulations. INTERFACE Bi-Directional RS 232C with software gfin CDp H Meter.
According to the Food and Drug Administration (FDA), the goal of validation is to: “ Establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” It is a requirement for Good Manufacturing Practices and other regulatory requirements. An quantitative approach is needed to prove quality, functionality, and performance of a pharmaceutical/biotechnological manufacturing process. Qualification: (Inspection, functional testing and documentation review) Is a part of the validation process which verifies module and system functional performance prior to being placed on-line and thereafter according to a standard operating procedure. “The operation which assure that an instrument readings are accurate with referenced to established standards”. When a specified usage (operating hours) has elapsed. Validation vs Calibration A calibration is a process that compares a known (the standard) against an unknown (test's device). Range 0.00 to 14.00 p H, 0.0 to 100°C Resolution 0.01 p H, 0.1°C Accuracy +/- 0.01p H, +/-0.5°C Calibration Up to 3 points, offset 0.1°C p H Slope Range 80% to 120% Auto Buffer Recognition p H 4.01, 7.00, 10.00 Auto Shutoff after 17 minutes Automatic Temperature Controller 0.0 to 50°C Operating Temperature 0 to 50°C Keys ON/OFF, HOLD/ENTER Probe Combination gel-filled epoxy body, Ag/ Ag Cl .
Scientific Calibration offers a full portfolio of pipette services, including calibration and repair.
We are ISO 17025 accredited, and calibrations come with a certificate of calibration and repair that meets or exceeds GLP, GMP, ISO 9000, and CAP requirements.
Brands You Trust: With ISO 17025 accredited services, you will receive a calibration certificate, which exceeds GLP, GMP, ISO 9000 and CAP requirements.
Whether you choose mail-in, on-site or pick-up, we will serve your equipment to the highest of standards.