Calibration of Analytical Instruments as Per ICH and USFDA Guidelines | Chapter 8 | Science and Technology: Recent Updates and Future Prospects Vol. 12

Calibration of analytical instruments in accordance with ICH and USFDA requirements is vital for ensuring the quality, reliability, and accuracy of analytical data. Calibration of analytical instruments such as UV-visible spectrophotometer, FTIR, HPLC, GC, Fluorimeter and Flame photometer was discussed. The focus was on practical methods to ensure accurate and reliable measurements in analytical chemistry, which is critical for maintaining quality control and meeting regulatory standards in laboratory analyses [1,2]. The guidelines provide a framework for validating the performance of instruments, including specifications for calibration frequency, acceptable limits, and documentation.

 

Author (s) Details

 

Vemuluri Padmabhushana Chary
Department of Pharmaceutical Analysis, Anurag Pharmacy College, Kodad-508206, Telangana, India.

 

D. Sireesha
Department of Pharmaceutical Analysis, School of Pharmacy, Anurag University, Hyderabad-500088, Telangana, India.

 

Please see the book here:- https://doi.org/10.9734/bpi/strufp/v12/2062

Comprehensive Analysis of Quality Management in Pharmaceutical Manufacturing Process | Chapter 2 | Advanced Concepts in Pharmaceutical Research Vol. 2

 The objective concerning this topic is to study the limits which are responsible for the status output. The data stresses the importance of quality in the drug industry, defining it as intersection customer needs and expectations. Quality limits include fitness for use, consumer satisfaction, and conformance to requirements. Quality Assurance (QA) focuses on processes, record-keeping and audits, encompassing all determinants affecting product kind, including Good Manufacturing Practices (GMP). Current Good Manufacturing Practice (cGMP) regulations are main to ensuring consistent drug quality and safety. Quality Control (QC) manages daily quality administration, from raw material testing to things produced release, requiring well-trained work force and suitable equipment. Calibration asserts equipment accuracy for trustworthy measurements. Validation ensures processes and orders consistently produce safe and productive products, covering supplies, processes, cleaning, computer systems, strength testing, regulatory agreement, and comprehensive documentation. These ingredients collectively uphold drug quality and regulatory agreement.

Amol S. Deshmukh,
Indrayani Vidya Mandir’s Krihnarao Bhegade Institute of Pharmaceutical Education and Research, Talegaon Dabhade, Pune-410507, India.

Pravin R. Dighe,
S.M.B.T. College of Pharmacy, Dhamangaon, Nashik-422403, India.

Vijay R. Mahajan,
S.M.B.T. College of Pharmacy, Dhamangaon, Nashik-422403, India.

Vikas D. Kunde,
Pravara Rural College of Pharmacy, Chincholi, Nashik-422102, India.

Ganesh S. Mhaske,
Indrayani Vidya Mandir’s Krihnarao Bhegade Institute of Pharmaceutical Education and Research, Talegaon Dabhade, Pune-410507, India.

Shyam S. Awate,
Indrayani Vidya Mandir’s Krihnarao Bhegade Institute of Pharmaceutical Education and Research, Talegaon Dabhade, Pune-410507, India.

Please see the link here: https://stm.bookpi.org/ACPR-V2/article/view/12334

Design of Radiosonde Based on Arduino Pro Mini Using BME280 Sensor | Chapter 7 | Techniques and Innovation in Engineering Research Vol. 5

 Aims: To produce cheap Radiosonde instruments accompanying high veracity, which are expected expected used as a citation in developing above aerial scrutiny instruments so concerning reduce remark costsStudy Design: Design of Radiosonde Based on Arduino Pro Mini Using BME280 Sensor.Place and Duration of Study: Department of Physics, Udayana University, and Indonesian Agency of Meteorology, Climatology, and Geophysics (BMKG), Region-III Badung, between June 2022 and August 2022.Methodology: Calibration is done by equating the output worth of the BME280 sensor and the BMKG calibration standard finish. The calibrated limits are temperature, moisture, and air pressure.Results: Radiosonde instruments based on Arduino Pro Mini utilizing the BME280 sensor have been created. The measurement veracity obtained for the hotness parameter is 99.9968% accompanying uncertainty (U95) of ±0.18∘C , the humidness parameter is 99.296% with changeableness (U95) of ±2.9%RH, the air pressure parameter is 99.99998% accompanying uncertainty (U95) of ±0.15 hPa. The veracity value displays that the resulting finish has a good level of accuracy to the standard finish.Conclusion: In this research, has been produced a Radiosonde implements at a low-cost accompanying high veracity and precision, that have been measure with BMKG standard tools.

Author(s) Details:

Ida Pertiwi Sari,
Department of Physics, Udayana University, Bali, Indonesia.

Anak Agung Ngurah Gunawan,
Department of Physics, Udayana University, Bali, Indonesia.

I. Made Satriya Wibawa,
Department of Physics, Udayana University, Bali, Indonesia.

I. Ketut Putra,
Department of Physics, Udayana University, Bali, Indonesia.

Mahmud Yusuf,
Indonesian Agency of Meteorology, Climatology and Geophysics (BMKG), Region-III, Badung, Bali, Indonesia

Please see the link here: https://stm.bookpi.org/TAIER-V5/article/view/9740

Study on Calibration of ASM1 for Carbon and Nitrogen Removals of Riqqa Activated Sludge System, Kuwait| Chapter 7 | Recent Progress in Science and Technology Vol. 1

 The second-best wastewater treatment convenience in Kuwait, the Riqqa plant, has recently displayed signs of operating in shaky conditions. A study was currently carried out by Kuwait Institute for Scientific Research to assess plant efficiency and identify ultimate likely sources of the issue. The plant's stimulated sludge system was shaped using ASM1 in the SIMBA imitation package to carry out these goals. In Kuwait, ASM1 was being used for the first occasion to simulate a total activated sludge arrangement.  This study uses routinely calculated wastewater quality dossier over a long period of time to measure ASM1 to the carbon and nitrogen removals of the Riqqa stimulated sludge system. COD fractionation and early estimations of the measurement parameters were two together aided by respirometer study.  Validation results showed agreement 'tween the measured and fake effluent COD, NH4-N and NO3-N long-term dynamic simulation. The grown model can be secondhand in the evaluation and diagnosis of bureaucracy performance. Also, got values of ASM1 limits will be useful in modelling different activated mud systems in the country and the region.

Author(s) Details:

A. Abusam,
Innovative Technologies for Wastewater Treatment and Reclamation Program, Water Research Center, Kuwait Institute for Scientific Research, Kuwait.

Please see the link here: https://stm.bookpi.org/RPST-V1/article/view/9093

Study on the Biomass Production Assessment of Wheat Varieties under Semi-arid Conditions of Rajasthan through Using Info Crop Model | Chapter 11 | Current Topics in Agricultural Sciences Vol. 5

 The current study used a three-replication double split plot design with 36 treatment combinations, including main plots: irrigation levels (0.6 Etc, 0.8 Etc, 1.0 ETc, and 1.2 ETc), sub plots: varieties (Raj 4120, Raj 4079, and Raj 4238), and sub-sub plots: sowing dates (15th Nov., 30th Nov., and 15th Dec.). The Info Crop model was calibrated and verified using experimental data from three wheat cultivars (Raj 4120, Raj 4079, and Raj 4238) sown at various times and with varying irrigation schedules. The model's performance was assessed using average error (Bias), root mean square error (RMSE), Normalized RMSE (nRMSE), and index of agreement (d), with the simulated and measured durations agreeing well. Based on these findings, it can be stated that the model accurately predicted growth characteristics such as leaf area index, biomass output, and yield, and that it reflected the temporal patterns of yield variability relatively well when compared to observed field data (error percent between 10-20).

Author(S) Details 

Arjun Lal Prajapat
Sri Karan Narendra Agriculture University, Jobner – 303329, India.

Rani Saxena
Sri Karan Narendra Agriculture University, Jobner – 303329, India.

Sonu Jain
Sri Karan Narendra Agriculture University, Jobner – 303329, India.

Mahesh Sharma
Sri Karan Narendra Agriculture University, Jobner – 303329, India.

Bhuwanesh Didal
Sri Karan Narendra Agriculture University, Jobner – 303329, India.

View Book:- https://stm.bookpi.org/CTAS-V5/article/view/5264

Optimization of a Three-Axes Teslameter for the Calibration of the Next Generation Undulators | Chapter 4 | New Insights into Physical Science Vol. 9

 There are many commercial and scientific uses for the measurement of a three-axis magnetic field with high spatial resolution. One particular experimental application includes characterising in free electron lasers the field map of insertion devices. This work presents the development of a new, reduced form-factor, digital teslameter with three axes. At the Paul Scherrer Institute (PSI) for the Athos soft X-ray beamline, this instrument will be used to classify the SwissFEL insertion units. The setup would move along the full length of the undulator along with a Hall probe at the middle of the cross-sectional region of the undulator on a specially designed basis. Minimal vibration device, thereby obtaining a complete map of the magnetic field in the three-axes. For the three-axis interface to a Hall probe, the teslameter integrates analogue signal conditioning, a linear absolute encoder interface and a high resolution 24-bit analog-to-digital converter. This compares with the old instrumentation setup used, consisting only of analogue circuitry with digitization performed by proprietary hardware externally to the instrument. The new instrument also offers a very detailed map of the magnetic field in the μT range with simultaneous location encoder readings at an accuracy of ±3 μm. The innovation of the instrument is the provision of an integrated optimised solution with a very compact size and efficiency comparable to the best state-of-the-art teslameters currently on the market. Initially, a brief history on magnetic field instrumentation is given, followed by the actual creation of the novel teslameter hardware. It follows the standardised calibration method that is critical to optimising this precision instrument's efficiency. Among other parameters, the output results obtained outline the instrument's noise, measurement accuracy, repeatability and frequency response. These are studied in order to eventually establish an informative understanding of the magnetic properties of insertion devices that need to be modelled and characterised.

Author (s) Details

Johann Cassar
Faculty of Engineering, University of Malta, Msida, MSD 2080, Malta.

Andrew Sammut
Faculty of Engineering, University of Malta, Msida, MSD 2080, Malta.

Nicholas Sammut
Faculty of ICT, University of Malta, Msida, MSD 2080, Malta.

Marco Calvi
Photon Science Division of the Paul Scherrer Institute, 5232 Villigen PSI, Switzerland.

Sasa Dimitrijevic
Sentronis ad, 18115 Nis, Serbia.

Zarko Mitrovic
Sentronis ad, 18115 Nis, Serbia.

Sasa Spasic
SENIS, Hertizentrum 11, 6300 Zug, Switzerland.

Dragana Popovic Renella
SENIS, Hertizentrum 11, 6300 Zug, Switzerland.


Radivoje S. Popovic
SENIS, Hertizentrum 11, 6300 Zug, Switzerland. 


View Book  :- https://bp.bookpi.org/index.php/bpi/catalog/book/327