Development and Manufacturing of World Grade Programmable Thermal Cyclers for Polymerase Chain Reaction in Pakistan: A Case of Biomedical Engineering

Abstract

Manufacturing is the backbone of a modern state and has a direct impact on life style of a common person of a society. We present here the development and manufacturing of Polymerase Chain Reaction (PCR) machines by the Pakistan Atomic Energy Commission (PAEC), Pakistan. Steps of the development and manufacturing of PCR machines are explained. Important design features of MERADD PCR machines and their implementation are documented here. Results of the MERADD PCR machine are compared with those of competitive imported machines. MERADD is the sole manufacturer of PCR machines in Pakistan. Quality assurance and cost analysis are also given. MERADD PCR machines produce as good results as by the imported machines, but cost is significantly lower. This paper is useful for a broad community of developers/manufacturers of medical devices and biomedical engineering in developing countries around the world. the target DNA, primers, nucleotides and DNA polymerase. Heater at the top of the mixture is to supress vapor formation in the tube. Temperature of the heater remains the same and is kept above the denaturation temperature. Types of PCR machines Many variants of PCR machines have been developed. Some of them are commercially available. We do not review here all the available or reported PCR machines but are documenting only leading or general types. Conventional PCR machine: It is also called qualitative PCR. Its components are of macroscopic size. Normally, it uses Peltier cell [17] thermal cycling. Other parts include power system and control system. DNA mixture of macroscopic size (fraction of a milliliter) is needed. Several samples can be processed or analyzed simultaneously. DNA amplification up to millions is possible in hours' time scale. Please see details later in the paper. Multiplex PCR machine: In a multiplex PCR machine, more than one DNA targets are amplified simultaneously in the same reaction. Since its first description in 1988 [18], multiplex PCR has been used in several areas of DNA testing and diagnostics. Important considerations in the Multiplex PCR are DNA primers, recipe of the primer mixture, optimization of Multiplex PCR cycling conditions and optimization of Multiplex reaction components [19,20].