Robotics Engineering for Pharmaceutical Manufacturing and QC Laboratories

Off-line engineering of four kinds: a staging or weighing aid for a QC bench, a fixture that challenges code readers and aggregation stations, an interface or changeover module for one point on a packaging line, and a sensor trial for pack inspection. Each is built and tested with placebo or dummy material. Research labs sit on Biotechnology, device development on Medical Devices, bulk chemistry on Chemicals & Materials and hospital pharmacy on Healthcare.

No. Under revised Schedule M, qualification, validation of computerised systems, change control and release belong to the licensed manufacturer and its quality unit. We supply evidence those teams can use: a requirement trace, drawings, configuration, test protocols, raw data and a change log. If you adopt a design, it enters your own change control and qualification. We will not describe a prototype as approved for GMP, ready for inspection or fit for batch use.

Not through this page. Sterile and aseptic processing, isolators, potent, hormonal and cytotoxic products, biologicals, radiopharmaceuticals and narcotic or psychotropic substances each need specialist owners, containment or licences that we do not hold. Our trials use only inert stand-ins agreed with you. If a project would reach one of these areas, we stop and can help you write a requirement for a qualified specialist.

Yes, off-line. We build a fixture that presents dummy cartons, bottles or shipper loads to your reader or a candidate station, with a challenge set of good, damaged, wrong-batch, duplicate and missing codes. It can carry the rule 96 data for Schedule H2 brands or API labels, with product codes from your SOP, or your export customer's specification. We never handle live serial numbers or connect to production serialisation or reporting systems.

Your regulatory and quality team should confirm that. Revised Schedule M under the Drugs Rules, 1945 sets GMP for premises, equipment and computerised systems, and rule 96 sets bar code and QR requirements for listed brands and for APIs. The DGFT export track-and-trace procedure has been withdrawn. Workplace safety falls under the OSH Code 2020 and state rules. This is scoping, not legal advice.

They remain yours, on terms signed before anything is shared. We agree in writing who may read them, where they are stored, how long they are kept and how they are returned or deleted. Trials run on dummy batch numbers and test codes, so live serials, batch records and formulas are never needed. Your pack images train no other models without written permission.

Yes, if the work is bounded, for example a reject-chute prototype, a reader mount with its challenge set or a rig controller. Tell us the area, the documents your QA expects and the skills involved. We put forward engineers who are free now, and your team interviews them. They follow your SOPs, gowning and deviation reporting, and they do not take on QA, validation or release roles.

Cost follows the step and formats involved, the number of challenge cases and repeat runs, any time at your site or with the machine maker, and documentation. Once the trial ends, your team gets the files, results and limits with a recommendation: adopt through your change control, simplify, buy a vendor system or stop. Spares and repairs are separate agreements.