DEMACH / PHARMA COMPONENTS
Filling and dosing needles
Needles for liquid dispensing in filling machines, for sterile and non-sterile applications according to process requirements.
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AISI 316Stainless-steel parts: AISI 316
Ra ≤ 0,4 µmSpecified finish: Ra max. 0.4 µm
CUSTOM MADEFrom drawings, specifications or samples
01 / CUSTOM ENGINEERING
From drawings, specifications or samples
Materials, relevant surfaces, geometries and documentation are defined in the supply specification. Low-roughness surfaces support cleanability. Components intended for sterile processes are not supplied sterilized.
Flat tips and side holes to suit the application
Connections, flanges and filling-machine integration
02 / REAL COMPONENTS
From our workshop to your line.
DEMACH components: supplied product photographs
03 / REGULATED ENVIRONMENTS
Engineered for your pharmaceutical process.
EU GMP and Annex 1 guide sterile medicinal product manufacturing and contamination control. AIFA oversees pharmaceutical manufacturing sites in Italy; FDA cGMP is the US framework. Component materials, cleanability and integration are specified for the customer’s process.
GRADE A
Critical zone for aseptic operations with exposed product, such as filling.
GRADE B
Background to Grade A in aseptic processes without an isolator.
GRADE C
Less critical stages, such as preparation of solutions for sterilizing filtration.
GRADE D
Preparatory stages, including equipment cleaning, as defined by the process.
Grades A–D classify environments, not individual needles or syringes. With isolators, the background grade depends on configuration and risk assessment. Qualification, validation and the contamination control strategy (CCS) remain facility-specific. These references do not constitute AIFA or FDA certification of a component.
Regulatory references
04 / YOUR NEXT COMPONENT
Request a quotation ↗Let’s discuss your application.
Send the machine model, application, drawing or sample and quantity. We will help define the configuration, quotation and order.
sales@demach.it