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Validation

  • Validation

IQ Documentation

The installation qualification phase is the initial step in the validation process. It entails the verification and documentation of the correct installation of systems, facilities, and equipment in alignment with predefined specifications and manufacturer guidelines. 

OQ Documentation

OQ Documentation, or Operational Qualification Documentation, is a crucial part of equipment validation, especially in regulated industries like pharmaceuticals and medical devices. It focuses on verifying that equipment or systems operate as intended within their specified operating ranges. 

PQ Documentation

A “PQ document” refers to a Pre-Qualification document used in procurement processes, particularly in construction and supply chain management. It outlines the criteria that potential bidders or vendors must meet to be considered eligible for a specific project or contract. 

Clean Room/HVAC

Cleanroom Validation/HVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards. We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us. Akshar calibration performs the HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.

PLC

Recently, Computerized Systems (CS) using Programmable Logic Controllers (PLC) have been utilized for controlling drug manufacturing equipment (hereafter, manufacturing equipment). Such a CS is referred to as a PLC-Based CS (PBCS). Upon the use of PBCS, the regulatory authorities require drug manufacturers to prove that their CS has adequate functions and performance. Along with the sophistication of manufacturing equipment functions, the PBCS functions have also become complicated. This has made it difficult to prove the adequacy of the functions and performance. In this research, we propose methods for proving the adequacy of the functions and performance of PBCS with complicated structures. Drugs are essential for maintaining human life and health, while they have significant influence on the human body.

Cold Chain

Obligations no longer stop at the warehouse door. Cold chain qualification is now actively audited and enforced by regulatory bodies. Ensuring quality of product and patient safety highlights the emphasis for good cold chain management practices. Implementation of good cold chain practices is essential to ensure that proper handling, storage and distribution of environmentally labile pharmaceutical products are adhered to by all pharma companies. As a third of all cold chain shipments are now accounted for by pharmaceutical and biotechnology sectors, Akshar calibration Ireland provides a service that can validate all areas of this industry segment whilst satisfying regulatory requirements This qualification process is a step-by-step temperature and humidity monitoring study to insure that at each stage of product storage and transportation the product remains within acceptable environmental conditions.

Akshar calibration provide services in the following areas:
• Risk management approach to cold chain
• Raising awareness with all staff involved in the cold chain
• Testing of packaging systems to ensure compliance
• Explanation of procedures involved
• Development of SOPs for correct transport of products
• Temperature and humidity mapping of all transport methods
• Conducting worse-case comparison studies
• Analysis of results and comparison to previous stability studies
• Validation Master Plan
• Preparation of Protocols
• Risk Assessment

Thermal

The pharmaceutical industry is a highly regulated environment based on research, evidence, record-keeping and validation. Our experience and expertise will give you a clear, compliant and transparent validation package. The term "Thermal validation" is the process of validating / qualifying equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for.

Our range of bespoke services to the pharmaceutical, biotechnology and healthcare industries. We specialise in the validation of international standards as per WHO TRS 961, ISO/IEC:60068, HTM 2010

Validation and Monitoring equipment (Wired & Wireless) are major responsibilities comes under thermal validation. Well maintained and calibrated equipment ensures that it operates at peak performance and complies with regulatory requirements.

Steam Compressed Test

• To Detect Non‐condensable Gas, Dryness, Superheat
• To qualify plant/utility/clean/pure steam generators, steam distribution systems and steam supplies to autoclaves in accordance with cGMP (Orange Guide), HTM 01, HTM 2010: 1994, HTM 2031: 1997, EN 285: 2006, AAMI ST79, ISO 14937:2000, ISPE Baseline Guide for Steam and Water and PDA Technical Reports No. 1 & 48.
• To test your physical steam quality with assured and repeatable results in no time at all.
• To satisfy your Regulator/QA immediately!

Compressed Air Validation

Compressed air is air kept under a pressure that is greater than atmospheric pressure. It serves many domestic and industrial purposes. Compressed Air is a vital energy source and is utilized in multiple operations in industries. When properly treated, Compressed air is regarded as a safe, clean utility, as compared to other energy sources. Compressed provides the energy source for pneumatic conveyers that transport liquids, powders and moisture sensitive product throughout the plant.

The Quality of Compressed air is important to ensure that product is safe. The most important parameters in specifying Compressed air quality are:
• Dew Point
• Oil Content
• Particulate matter
• Moisture Content
• Viable Count.

The International Standard Organisation sets quality standards for Compressed air as ISO:8573.
Akshar Calibration is a reliable calibration service provider offering accurate and efficient solutions for a wide range of measuring instruments.

Our laboratories are equipped with a wide range of measuring instruments of highest accuracy

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