Our Life Sciences Solutions includes:

COMPLIANCES  (21 CFR Part 11) and DIGITAL SIGNATURE VERIFICATIONS      

DIGITAL VERIFICATION21-cfr-part-11-compliance-s-250x250

 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.

Reckers Mechatronics has experts from the industry who have implemented similar projects and can offer best of services in this segment to its clients. We also have expertise in electronic Batch Production Report configuration in control system. 

REACTOR AUTOMATION

RA

The batch reactor is the generic term for a type of vessel widely used in the process industries. The batch reactors are used for a variety of process operations such as solids dissolution, product mixing, chemical reactions, batch distillation, crystallization, liquid/liquid extraction and polymerization. In some cases, they are not referred to as reactors but have a name which reflects the role they perform (such as crystallizer, or bioreactor).

A typical batch reactor consists of a tank with an agitator and integral heating/cooling system. These vessels may vary in size from less than 1 litre to more than 15,000 litres. The main parameters to be controlled are temperature of the mass, agitation speed ,pressure and other parameters of the reactants like pH, Conductivity, Dissolved oxygen, Turbidity etc.

Reckers Mechatronics have good expertise in automation of reactors used in Pharmaceutical ,Fine Chemicals and other Chemical Process Industry. We undertake turnkey projects which include Instrumentation ,Electrical and Automation. We can offer total end to end solution for these processes.

DISTILLATION COLUMNS

DC

A fractionating column or fractionation column is an essential item used in distillation of liquid mixtures so as to separate the mixture into its component parts, or fractions, based on the differences in volatilities. Fractionating columns are used in small scale laboratory distillations as well as for large-scale industrial distillations.

We have done automation for many distillation columns including safety automation for more than 100 distillation systems.

MULTI EFFECT EVAPORATORS

EVZAPORATORS

A multiple-effect evaporator, as defined in chemical engineering, is an apparatus for efficiently using the heat from steam to evaporate water.[1] In a multiple-effect evaporator, water is boiled in a sequence of vessels, each held at a lower pressure than the last. Because the boiling temperature of water decreases as pressure decreases, the vapor boiled off in one vessel can be used to heat the next, and only the first vessel (at the highest pressure) requires an external source of heat. While in theory, evaporators may be built with an arbitrarily large number of stages, evaporators with more than four stages are rarely practical except in systems where the liquor is the desired product such as in chemical recovery systems where up to seven effects are used.

We have experience in providing total turnkey solution in Multi Effect Evaporators including Electricals,Field Instrumentation and Control System.

FERMENTATION CONTROL

FA

Industrial fermentation is the intentional use of fermentation by microorganisms such as bacteria and fungi to make products useful to humans. Fermented products have applications as food as well as in general industry. The rate of fermentation depends on the concentration of microorganisms, cells, cellular components, and enzymes as well as temperature, pH[2] and for aerobic fermentation[3] oxygen. Product recovery frequently involves the concentration of the dilute solution.

We have experience in fermentation control system and provided SCADA and field Instrumentation for controlling critical parameters like temperature ,Dissolved Oxygen ,pH and other critical parameters.

Industrial dryers are used to efficiently process large quantities of bulk materials that need reduced moisture levels. Depending on the amount and the makeup of material needing to be dried, industrial dryers come in many different models constructed specifically for the type and quantity of material to be processed. The most common types of industrial dryers in Pharmacutiacl Industry are fluidized bed dryers, rotary dryers, Tray Dryers, Spray Dryers ,Vaccum Dryers etc.

We have good experience in providing total turnkey solution for dryer application

CIP/SIP 

CIP       

CIP/SIP Systems are designed for purification and sterilization of pharmaceutical units, systems and single components.

We have done good number of CIP/SIP system automation for our clients.

Printing Process Of CIP/SIP Machine

“We have developed the printing mechanism for the complete process through the HMI  using MicroLogix 1400 PLC (Allen Bradley) &Panel View Plus 600 (Allen Bradley) hardware & RSLogix 500 software. ”.

Challenge

To print the machine actual working process step by step by keeping the print of all related parameters

Being taken into eff­­­­­e­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ct as per their required set points through the HMI without any time delay .

Solution

We have developed the application as strictly according to the working mechanism of the machine with each change of phase is being printed and specified on the print as required without any time delay. Even the phase changes in the process with milliseconds gap is printed as per the conditions of the working of machine.

What is CIP/SIP?

Clean-in-Place (CIP) is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly. The benefit to industries that use CIP is that the cleaning is faster, less labor intensive and more repeatable, and poses less of a chemical exposure risk to people. CIP started as a manual practice involving a balance tank, centrifugal pump, and connection to the system being cleaned.CIP has evolved to include fully automated systems with programmable logic controllers, multiple balance tanks, sensors, valves, heat exchangers, data acquisition and specially designed spray nozzle systems. Simple, manually operated CIP systems can still be found in use today. The Steam-In-Place (SIP) System is responsible for repeatedly steaming areas of product contact, including vessels, flow paths, and sample ports. This may be done to reduce the bio-burden on the system, or to kill harmful materials at the end of a batch. A typical SIP system will ensure that all areas being steamed have been exposed to live steam for an adequate time to ensure the desired “kill”effect.The steam system must be able to measure and control steam temperature, pressure, and/or flow to ensure adequate steaming. Calculation of Fahrenheit or other measures is often required to meet process needs.

System Configuration and Implementation

The system has the two micrologix 1400 plc’ whose data is shared over the Modbus RTU through messaging to the main control panel PLC. PVP600 (HMI) is used to Operate the system and to print the process. Previously the system is running the printer through the plc serial port. But due to the insufficient memory no editing to the process and print is possible and this is the major challenge during the application development. And this is the reason why we choose to print the process through HMI as it facilitates us to develop the application with almost zero use of memory of PLC and logic correction to process as required by making the memory free.