Products&Services

Welcome to the Independent Testing Lab.

The staff of the Independent Testing Laboratory has over 15years of combined test experience and expertise!

Consider our staff your private industry consultant providing a full-range of electrical,  air velocity ,HEPA,ULPA Filter PAO Leak Test, Noise Level Test, Vibration Test, Personnel protection Test and many others to answer your most difficult technical service or R&D questions from prototype testing to failure forensics.

In general, if your company manufactures a medical device, or your equipment is a part of pharmaceutical technology, you  equipment will be required to implement a  compliant quality management system. “Analytica and High Technology ” can help you implement a quality system that meets the  Good Manufacturing Practice -  or modify your existing quality system to meet the GMP requirements. We have implemented quality management systems for hundreds of medical device companies.

Our highly skilled, experienced and professional staff supports your testing needs quickly and efficiently, while ensuring the highest level of confidentiality.

The Independent Testing Laboratory performs tests for medical and Laboratory manufacturers,  end users, and universities, while assisting R&D efforts in related fields. We can perform test for most industrial, commercial and Government applications.

Validation Services

Whenever you start a new production line or go through a production change, you need the assurance that every aspect is being handled correctly. Our validation experts provide exactly that – from process validation, to cleaning validation & revalidation.

Are you changing from one product to another on your production line?

Are you about to start your new production and need to prove and document that your process is producing the required quality?

Have you recently made a change in your production processes that could influence your product characteristics or effectiveness?

Our validation services provide the help you need with these and any other goals – to optimize the process parameter for your production.

Addressing your specific validation requirements


Based on our risk assessments, we offer advice and support for the validation of both stand-alone production units and large pharmaceutical and biotechnology facilities – from preparing validation master plans and validation plans, to supporting the execution, reporting or reviewing of validation documentation.

Our validation services include

Preparation of validation master plans

Preparation of plans for the validation of analytical methods

Preparation of process and cleaning validation plans

Support in the execution of validation plans

Preparation of validation reports 

Revalidation


Qualification

In the pharmaceutical and biotechnology industries, qualification is an essential part of a production facility. Our goal is to provide you with optimum support to get your systems and equipment fully qualified in the most efficient way.

Our expertise in qualification has led to a proven and comprehensive approach. Some key aspects of our approach include:

A thoroughly executed risk analysis to ensure that all aspects are considered and that the qualification work is effective and efficient

The involvement of persons from different disciplines in the risk analysis

Qualification activities planned in close coordination with all engineering disciplines

Our qualification services include:

· Validation Master Plans (VMPs)

· Risk analyses

· Qualification plans for all project phases:

·Design Qualification (DQ), Installation Qualification (IQ),  Operational Qualification (OQ),Performance Qualification (PQ)

· Supplier audits

· Execution of qualification plans

· Preparation of qualification reports

· Preparation of GMP documentation

· Re-qualification

· Establishing change control processes within the framework of a project

· GMP conform calibration

· Cleanroom testing


Engineering

  •  Development of the concept of new pharmaceutical production;
  •   Design works under international standards and in compliance with Russian standard GOST P
  •   Complete delivery of clean rooms in accordance with GMP requirements and ISO 14644 standards (wall partitions, doors, floors, ceilings, lamps, filter checkers, ventilation grids, etc.);
  •   Delivery of special stainless furniture for clean rooms;
  •   Delivery of pharmaceutical technological equipment;
  •   Delivery of equipment for systems of production, allocation and storage of purified water and water for injections;
  •   CIP/SIP stations;
  •   Placing in service and installation of technological equipment;
  •   Validation of pharmaceutical manufacturing processes in compliance with requirements set by Russian and European standards and rules, project qualification, clean rooms and air conditioning systems, qualification, technological equipment and engineering qualification, validation of processes including preparation of overall validation package.

 

Conceptual Design

It is important to begin and end your project as smoothly as possible. Why not get design concepts that support fast and efficient project progress right from the start?

All projects differ, and your next one will be unique. But what all projects have in common is the need to get the maximum benefit from investments – whether dealing with expansions, modifications or new facilities.
 
We know what it takes to establish a solid foundation. Many factors influence project strategy choices – regulatory conditions, products, processes, time, staffing, quality, location, environmental aspects or cost. We consider all these factors and give our clients the best options for effective engineering.

 

 

Success Projects

Hand to Hand with Our Clients Business

 

Direct Connection 

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