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Design Qualification

In this first important step, the manufacturer plays a key role in supporting the customer during the design phases with the drafting of design qualification (DQ) protocols in which the compliance of the project with GMP must be demonstrated and documented; compliance with the User Requirement Specification must also be verified at this stage of validation. Upon successful completion of the DQ, production of the equipment is started, at the end of which the test qualification is performed. Planning of the Factory Acceptance Test (FAT) must be formalized on a protocol also subject to approval by the Buyer (engineering company for “turnkey” projects or directly by the final customer for other projects); the GMP regulations (European Commission, 2015b) indicate that, when appropriate and justified, the documentary verification and some tests made during the FAT do not have to be repeated during the installation qualification/operational qualification (IQ/OQ), as long as it is shown that the functionality of the results is not compromised by transport or installation. This aspect is very important because these activities - if properly carried out at the headquarters of the manufacturer - will speed up the on‐site qualification phases, significantly reducing project times and costs.

Installation qualification/operational qualification

Preparation and compilation of the IQ and OQ protocols are part of the usual practice for all supplies that require validation in ac[1]cordance with the standards adopted.

The IQ tests for an isolator are performed aiming to verify that the installation of the equipment has taken place in accordance with the project specifications, that the material used and the instrumentation are accompanied by the necessary certificates, that the connections to the utilities have been made in compliance with the requirements indicated in the manuals, that the HEPA filters are equipped with certificates, and that, in general, all the documentation necessary for the use and maintenance of the equipment is available in accordance with the provisions of the machinery directive (2006/42/EC).

During the OQ phase, it is necessary to identify the process parameters (critical control parameter and critical quality attributes), define the acceptability criteria and the sampling plans.

Qualification of the software equipment

An extremely important aspect is related to the qualification of the software equipment, especially when it works as a full SCADA system, that is, as real supervision and data acquisition control system. The qualification must follow the principles listed in the GAMP, guidelines issued by the International Society for Pharmaceutical on the correct approach to validating IT systems according to GMP. In addition, when the computer system is also used for digital data recording, the software must comply with the requirements expressed by the FDA in CFR‐21 part 11 to ensure data traceability and integrity.

GMP Regulatory and Process workflow Design

BioAir Scientist Team can support the customers in Performance Qualification, in the workflow design of the process inside the isolators according to the GMP rules.

ATMPs, which are mostly composed of live cells, are sterile and Non sterilizable drugs.

Good manufacturing practices (GMPs) are the guidelines that must be applied to the manufacture of any drug, including ATMPs, to ensure that the drug administered complies with minimum quality requirements. GMPs are made up of several chapters and annexes that accurately indicate all the control elements required during manufacture and on the product itself. These elements include controls on raw materials, reagents, excipients or other additives, suppliers, quality controls and their methods, in process or on the final product, environments, machinery, personnel, cleaning methods, conservation and quarantine of products and materials, quality management, and so forth.

Applications

ISOMate® Cyto: Negative pressure isolator with bag-in/bag-out filter changing designed for handling of antiblastic, cytotoxic drugs, MAbs, R&D formulation of drugs and vaccines, manipulation of viral agents for diagnostic kits, etc.

ISOMate® Steri: Positive pressure isolator for sterility testing in a pharmaceutical environment, Grade A handling of products that require bio-confinement.

For both versions, it is possible to choose between options with 2 or 4 gloves, with an additional glove on the pass-through hatch for the transition between Grade D environment and the Grade A inner work area. Pass-through hatches can be 1 or 2, connected to the Grade A work area. Another choice is between painted or full stainless-steel versions.