Contamination, media fills, reject rates, a new line, a transfer or choosing a contract manufacturer: a specialist expert comes to your site quickly, backed by our back office.
Troubleshooting: contamination, cross-contamination, media fill failures, visual inspection, excessive reject rates.
Projects and continuous improvement: for your new aseptic lines, bulk or fill & finish – layout, validation master plan, equipment design, URS, cleaning validation.
Our experts have been designing, building and operating isolator and RABS lines for more than 30 years. They develop and deliver the operating and maintenance training for this equipment themselves, and support your projects from design through to deviation investigations.
Isolator or RABS, open or closed: a reasoned choice based on the process, the products (including cytotoxic and highly potent compounds), throughput and your contamination control strategy. URS writing, glove-port ergonomics validated on a mock-up, choice of transfer systems (RTP ports, tunnels, decontamination airlocks), FAT and SAT follow-up.
Implementing the requirements of the revised Annex 1 in your aseptic filling isolators: first air, management of indirect product-contact parts, preventive measures against the contamination risks specific to production isolators.
Development and implementation of decontamination with all current hydrogen peroxide techniques, vapour or nebulised: distribution mapping, biological and chemical indicators, control of aeration and of peroxide residues on product-contact surfaces, cycle development and validation.
Qualification of isolators and RABS (IQ, OQ, PQ), enclosure leak-tightness and glove integrity, unidirectional airflow and particle classification, validation of decontamination cycles, inclusion of glove interventions in media fill tests.
Operating and maintenance training: glove manipulations, interventions, glove change and testing, preventive maintenance. Deviation investigations: loss of glove integrity, non-conforming decontamination cycle, out-of-limit environmental monitoring result.
2-day training course: isolators for aseptic filling →Controlling project costs and time to market, with a reliable process at the receiving site: definition of scope and critical points, team organisation, scale-up, validation, change control review.
Aseptic process simulation is the ultimate check that a process can produce a sterile product. See the Media Fill Test topic →
Assessment of your cold chain against GMP, WHO and customer requirements, risk analysis and gap analysis, root causes, remediation: stability studies, TOR, packaging and shipping specifications, temperature monitoring in transit.
Four modules to assess a target laboratory: FDA/EMA regulatory compliance (mock-inspection-style audit), technical and production, economic efficiency, human resources. Reputation studies through our network.
Three workshops: definition of needs and a first list from our database, shortlist of 2 to 3 assessed contract manufacturers and audit programme, then call for tenders, quality agreement and contract.
Assessment and management of your industrial projects, from preliminary design to routine production: a new site or production unit, a new aseptic line, a capacity extension, a relocation or the industrialisation of a new product. Our project managers come from the pharmaceutical industry and know the constraints of a GMP environment.
Definition of the industrial project against your objectives, choice of technologies and confirmation of their availability, initial review of the legal (access to technologies), quality and regulatory environment. A preliminary study to estimate the budget and implementation timeline depending on the partners and technologies chosen.
A review of your situation from the commercial, legal, technical, regulatory, human and financial angles. Market studies for the products under consideration, choice of processes and technologies, regulatory strategy, phased capital budget for buildings and key equipment, headcount and skills needs, recruitment plan and provisional schedule.
Set-up of governance and steering committees, detailed schedule and critical path, budget and commitment tracking, risk register, coordination of engineering firms, suppliers and contractors. We act as owner's engineer or take over project leadership.
Validation master plan, sequencing of FAT, SAT, IQ, OQ and PQ, process and cleaning validation, first media fill tests, team training and procedure writing, preparation of the pre-opening or site-change inspection.
See also: owner's engineer and project management, Engineering page →Lead expert: Christian Agier
Axys-Network brings its expertise in six areas:
We work on any issue affecting the quality of a BFS product.
37 years of Blow-Fill-Seal experience: ten years in sterile manufacturing of ophthalmic products as production director and interim qualified person (Laboratoires H. Faure), then 27 years in injectable products as quality director and qualified person (Laboratoire Aguettant). For five years he was secretary of BFS IOA Europe, the international association of BFS operators.
Context: an Indian biotech manufacturer produces an injectable product on behalf of a major US group, for the US market. Its aseptic practices have to meet FDA expectations.
Intervention: 5 days of on-site expertise to improve aseptic practices, followed by on-site training of 200 people involved in manufacturing.
Result: the products are marketed in the United States.
Our interim managers come from the same pool of aseptic process experts.
