Skip to main content Skip to search Skip to main navigation
Question of the Week | GMP-Verlag

How do Components like Filling Needles and Laminarisators Affect First Air Integrity?

Components in the airflow path, such as filling needles, laminarisators, and sensors, must be aerodynamically designed, sterile, and particle-free to avoid disrupting First Air. While some airflow interruptions are unavoidable, these must not compromise the protective airflow or cause turbulence that could introduce contaminants.

[GMP Compliance Adviser, Chapter  First Air: Core Aerodynamic Barrier for Aseptic Processes ]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The free demo access is non-binding and ends automatically after 7 days.

Test it now for free

You may Also be Interested in the Following Articles

News: Medical Devices

EMA: Harmonisation of Combination-Product Quality Assessment

EMA’s Combination Products Operational Group (COMBO) is working to improve alignment between notified body opinions (NBOps) and pharmaceutical quality assessment, according to its report on the meeting held on 8 October 2026.
Read more
PIC/S: Revision of the Framework for International Cooperation

PIC/S: Revision of the Framework for International Cooperation

PIC/S has revised the framework governing its international cooperation. The updated Pharmaceutical Inspection Co-operation Scheme, PIC/S 1/95 (Rev. 7), was adopted in Istanbul on 2 November 2026 and entered into force on the same day.
Read more
FDA Updates Framework for Coordinating Facility Evaluations and Inspections

FDA Updates Framework for Coordinating Facility Evaluations and Inspections

FDA has revised its framework for collaboration between the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII). Version 2.0 of the Concept of Operations (ConOps), effective October 21, 2026, supersedes the original June 2017 version.
Read more
Outsourced Activities in the GDP Environment Part III: Contract Giver and Contract Acceptor

Outsourced Activities in the GDP Environment Part III: Contract Giver and Contract Acceptor

For any outsourced GDP activity, there is a need for delimitation of responsibilities between a client (contract giver) and a contractor (contract acceptor). Read more about their roles and responsibilities in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

Read more
Question of the Week | GMP-Verlag

Who is Qualified to Conduct Self-Inspections within a Company?

Here's the question:
Read more
News: Europe

EU: Singapore Added to List of Recognised Third Countries for API Importation

The European Commission recognises Singapore’s GMP requirements and regulatory oversight of active substance manufacturers as equivalent to EU requirements. Once the decision enters into force (15 November), Singapore will join the EU list of recognised third countries for the importation of active substances.
Read more
Previous
Next