Blog

Equipment Validation For Pharmaceutical Equipment
04.21.20

Equipment Validation For Pharmaceutical Equipment

How Important is Equipment Validation in the Pharma Industry?

Disasters often stir humankind into constructive action. It was in the wake of the infamous “Contergan Scandal” that Good Manufacturing Practice (GMP) evolved in the United States in 1963 [1]. And, the issue of sterility in the parenteral market made two Food and Drug Administration (FDA) officials put forth the concept of validation in 1979 [2].

Pharma products have a direct impact on the health of the consumers. Ensuing quality of products is, therefore, a top priority for regulators. Dosage strongly impacts the percentage of the drug that reaches the site of action. Therefore, each batch of manufactured drugs must be of the same quality [3], meaning consistency is of paramount importance.

Equipment Validation documents evidence that a piece of equipment conforms with the required standards across all stages [4]. GMP ensures that quality is an integral part of a product and not merely tested in it [5]. Equipment validation is a component of GMP which guarantees that the equipment maintains the required standards and, as a result, consistently provides products of the necessary quality [5].

Cybernetik Technologies has successfully validated and delivered multiple pieces of equipment for the pharmaceutical industry. Our technicians engage with clients throughout the equipment validation process, while conforming with the US FDA Part 211 and Part 11, EU Annexe 11, and cGMP standards, and also drafting the necessary documents.

When the validated equipment is part of a larger process, the validation documents play another key, although indirect, role – that of rapid error detection. If the process output is not as expected, technicians need to pin point the error. They can safely rule out equipment defect because it is already validated [6].

 

Equipment Validation for Pharma Industry Equipment

Cybernetik Technologies implements validation for pharmaceutical equipment through the following distinct steps which include the documents mentioned therein:

1. Requirement Understanding:

a. Client URS (User Requirement Specification): is the starting point of the validation process and describes what performance the client expects out of the equipment [6]. Customers can either provide the client URS directly or our personnel create it after capturing their requirements.

b. Internal URS: converts client URS into a set of instructions and particulars for our technicians.

 

2. Design & Development: defines the various components of the equipment, their capacities, materials, location in the overall set up, and other relevant features. Two documents/phases are particularly important:

a. Functional Design Specifications (FDS): describes how the system will perform its expected operation. FDS is the source for functional design requirements.

b. Detailed Design Specifications (DDS): is the source for the detailed design requirements and explains how to build the system.

FDS and DDS are normally verified during qualification or commissioning.

 

3. Design Qualification (DQ): ensures that the end user’s point of view is incorporated in the design process.

 

4. Factory Acceptance Testing (FAT): analyses whether the equipment performance conforms with the end user’s specifications. The venue for FAT is the Cybernetik shop floor. 

After a successful FAT, the customer and Cybernetik clear the machine for dispatch after certifying that it has been built to satisfy the User requirements (as per URS) and in accordance with FDA and DQ.

5. Installation Qualification (IQ): ensures that the client’s facility provides the appropriate setting for the piece of equipment [6]. IQ is based on DQ [7]. The three most common verifications during IQ are whether the equipment has adequate space allotted in the facility, is connected to the necessary utilities, and is installed with the required software [6].

Technicians also check if the equipment installation:

  • Integrates it with other equipment/systems [7].
  • Complies with qualification protocol and plan [8].
  • Considers all the equipments sub parts [8].
  • Makes arrangements for maintenance, calibration, and cleaning in future.
  • Utilizes the relevant national/international standards for calibration, measurement, and control.
  • Notes all equipment details such as model, serial number, spares, installation date, certificates.

 

6. Operational Qualification (OQ): is based on IQ. Technicians check if the:

  • Equipment operates as expected, particularly at the extreme operational ends [8] and follows the required operational sequence [7].
  • All equipment components operate correctly.
  • Technicians are correctly trained to operate the equipment.
  • Standard Operating Procedures (SOPs) are finalized and ratified.
  • All results are documented.

 

7. Performance Qualification (PQ): examines if the equipment/system performs consistently under load as required by the design specifications. Technicians create all the necessary documents for performance verification.

Finally

For building quality into pharma products, there is also a need to build unwavering precision into the equipment validation process. Because we cannot afford to forget that drugs are a lifeline for many!

Cybernetik Technologies has successfully validated pharmaceutical equipment for a diverse set of clients. Engaging with clients right from the design qualification stage, we walk them smoothly through the installation, operational, and performance qualification stages.

Contact us at +91 20 6790 9600 or sales.automation@cybernetik.com and experience the joy of seamless services.

 


 

References

  1. 1. http://biomanufacturing.org/uploads/files/305429596362804820-brief-history-of-gmps.pdf
  2. 2. https://ijpsr.com/bft-article/an-overview-of-pharmaceutical-process-validation-and-process-control-variables-of-tablets-manufacturing-processes-in-industry/?view=fulltext
  3. 3. https://irjponline.com/admin/php/uploads/1166_pdf.pdf
  4. 4. https://en.wikipedia.org/wiki/Validation_(drug_manufacture)
  5. 5. https://www.pharmatutor.org/articles/information-on-validation-important-tools-of-gmp
  6. 6. https://cdmo.ccrm.ca/blog/why-iq-oq-pq-important-manufacturing-cell-and-gene-therapies
  7. 7. https://www.fda.gov/media/92841/download
  8. 8. https://www.lfatabletpresses.com/articles/gmp-qualifications-validations-pharmaceutical-world
2.08.20

Case Study: Cybernetik Technologies’ Robotic Welding Solution for Aluminium Construction Panels

Case Study: Cybernetik Technologies’ Robotic Welding Solution for Aluminium Construction Panels

Productivity is the lifeblood of business. The construction industry is no exception. It is increasingly shifting towards brick-less buildings. Pour concrete into moulds formed by wall and slab panels, and a smooth structure is ready – the plaster coat is unnecessary. Seasoned builders complete up to one apartment floor in a day! Speed and smoothness apart, aluminium construction panels, also called formwork, minimize labour requirements. Simultaneously casting walls and slabs is possible. Less waste means the construction is eco-friendly. The formwork itself is corrosion-resistant and performs even with negligible maintenance. About a year ago, a reputed supplier of construction setups approached us. The project involved fabricating wall panels and slab panels from aluminium. Per usual, time was the critical factor. And the supplier was obsessed with quality and accuracy, flooded as the market is with players who dispense robotic welding in bits and pieces. Thoroughly aware of the unique requirements of aluminium welding and how robotic welding addresses these, our team streamlined the process – cutting down the welding time after manual loading to just six minutes! Programmable Logic Controller (PLC) allowed simultaneous (as opposed to sequential which takes longer) robot functioning while Human Machine Interface (HMI) boosted operational safety through fault diagnosis. Cybernetik Technologies delivered the first consignment within three months, well ahead of schedule.   Why Use Robots for Aluminium Welding? Robots are well suited for welding complex or large assemblies wherein the weld gun needs considerable manoeuvring [1]. Plus, they offer improved repeatability, consistency, quality, productivity, and safety [2]. And while doing all this, they bring down costs and the reliance on skilled welding personnel who are a rarity [2]. High strength-to-weight ratio [3] makes aluminium and its alloys an asset in multiple applications. Welding aluminium is tricky business though. Its low melting point of 6600C [4] […]

Read More
9.07.19

Three signs that you should change your bagging machine

Three signs that you should change your bagging machine

You may be running a big or a small business, but the packaging equipment is always a huge investment. The choice of packaging machine defines your ROI. Packaging machines are fascinating. As today every other industry is dependent on packaging operations, auto bagging systems became an integral part. Though the advancement in packaging is huge still there are some limitations in manual bagging. First is the quality and second is the bagging consistency Cybernetik offers fully automatic bagging machines which are ideal for your packaging needs. We also provide machine maintenance schedule and hands-on training to ensure that our customers fully understand the in and out the machine. Regular operation interruptions or long downtimes can be devastating for your business, and can even lead to safety hazards for your staff, making it critical to know when it’s time to upgrade or replace your equipment. So how would you know what is the right time to upgrade? More or frequent downtime If you are experiencing frequent upsets with the manual bagging machine and that leading to downtimes. It is not a good sign. The troubleshooting time and cost will be added to your operation cost. Inaccuracy and low production rates Operating with manual bagging machines is always a difficult job. Maintaining efficiency and product quality is a crucial task. Auto bagging not only helps you to meet your production rates but also keeps the quality better. Cybernetik offers automatic bagging machine which in accordance with the cGMP standards. The machines are ideal for the food and pharma industry where hygiene is important. Reduction in Speed You should not ignore when the machinery is running slower than the actual speed. this may lead to the frequent downtime and ultimately a loss of production hours. Our preventive maintenance schedule gives you the exact […]

Read More
21.12.17

Six-Axis Robots: What are they? Their Benefits & Integration

Six-Axis Robots: What are they? Their Benefits & Integration

Robotic manufacturers have designed and developed several different types of robots to fulfill the automation needs of various industries. The standard Six-Axis Robot is one of the most widely used among them.

Read More

Get in Touch