A

Aseptic: Definition, Meaning, and Applications Explained

Aseptic definition, differences to sterile and antiseptic as well as procedures

Aseptic Filling: Process, Advantages, and Applications

Aseptic Filling Explained: Definition, Advantages, and Industries.

Automated Optical Inspection

How it works, key benefits and use cases in regulated industries.

Audit explained in detail

An audit is an independent review to ensure compliance with standards, laws, and regulations.

Aseptic manufacturing – sterile production under clean room conditions

The aseptic manufacturing process and the associated sterile procedures ensure that medicinal products remain free from contamination.

B

Biotechnology: What is this?

Biotechnology uses biological processes and organisms to develop products and technologies.

C

Cleanroom Classes: Distinctions and Classification Features

Overview of cleanroom classes according to ISO and GMP. Standards, particle limits, and application areas summarized.

CGMP in the Pharmaceutical Industry – Good Manufacturing Practice at the Current Standard

CGMP: binding FDA regulations (21 CFR 210/211) for drug manufacturing explained—requirements, examples, and EU GMP context. Clear and practical.

Contract Filling

Contract filling explained: definition, reasons, process, and quality assurance according to EU-GMP/HACCP

Containment in the pharmaceutical industry – protection concept for people, products, and processes

Containment includes key measures to prevent contamination.

E

European Pharmacopoeia: the compendium for quality assurance and analysis in pharmacy

The European Pharmacopoeia (Ph. Eur.) is a compendium published by the EDQM on behalf of the Council of Europe and is a legally binding part of the official pharmacopoeia in Germany pursuant to Section 55 of the German Medicines Act (AMG).

F

Filling machines in modern production: Function, types, and areas of application

What exactly does a filling machine do? Definition, areas of application, and technical processes at a glance.

FDA compliant - Definition & requirements

What does FDA compliant mean? Clear definition, cGMP/21 CFR requirements, and practical examples for pharmaceuticals and medtech

H

Hermetic Sealing: Reliable Protection Against Contamination and Unwanted Substance Leakage

Hermetic sealing of cosmetic and pharmaceutical product packaging: effective protection

I

Injection solutions: sterile, safe, and effective

What is an injection solution? Learn how injection solutions are formulated, filled and controlled

ISO 9001 – Quality that pays off

ISO 9001 is an international standard for quality management systems, for process optimization and risk control.

Installation qualification

Installation Qualification (IQ) is the documented evidence that facilities, equipment, and systems have been correctly installed in accordance with EU-GMP Annex 15 and FDA requirements.

IIoT: Smart manufacturing for efficiency and product safety

IIoT enables efficiency gains, but also presents various challenges.

O

OEE (Overall Equipment Effectiveness) explained

Definition, calculation, practical examples, and realistic targets

Ophthalmics: Definition, Dosage Forms & Aseptic Filling

What are ophthalmics? A complete guide to definitions, dosage forms, manufacturing and sterile filling

P

Pharmaceutical manufacturing at a glance: From idea to medicine

Definition, objectives, and practical examples

Plant optimization - Sustainability and resource conservation through optimized processes

Plant optimization is the targeted improvement of production facilities – an overview of the most important aspects.

Production safety: essential for pharmaceutical production and beyond

Production safety ensures an uninterrupted process through GMP-compliant measures and protects both the product and the manufacturing site from contamination.

S

Sterile filtration: Microscopic pores against contamination.

Sterile filtration removes microorganisms using fine-pore filters (approx. 0.2 µm) without heat or chemicals, thereby producing a sterile medium.

T

Track & Trace mean in the pharmaceutical industry

What is Track & Trace in the pharmaceutical industry? Definition and essential background information at a glance.

U

USP (United States Pharmacopeia): Significance for Drug Production

The USP (United States Pharmacopeia) defines drug standards for quality, safety, and efficacy.