Liquid filler and sealer for pre-formed packaging (pharmaceutical products)
FDA, GMP, ATEX. CE
Gustav Obermeyer Spemaba GmbH & Co. KG
the task to find filling and packaging solutions for them.
Our machines for packaging applications in the pharmaceutical industry are produced GMP compliantly of highest quality to meet the special requirements to sterile products according to
FDA rules.
In this overview we like to show your our GMP and FDA compliant qualities of our solutions:
Conformity: GMP, FDA and all norms below
Materials, product-touching: Stainless steel AISI 316L or 316Ti, FDA-conform plastics
Materials, non producttouching; Mainly stainless steel AISI 304, closed profiles without notches, format parts FDA-conform plastics
Surfaces, product-touching: Ra <=0,8
Surfaces, non producttouching; Ra <=1,6
Fix connections Mainly welded and polished weld seams, if req.
Releasable connections: Aseptic-/hygiene-cappings or Clamp-connections
Machine frame Laminar-flow-compliant
Cleaning, product-touching; CIP-/SIP-capable filling machine or manual de-assembling (acc. to req.), when using peristaltic pump only need for exchanging hose and cleaning nozzle
Cleaning, non producttouching; Closed surfaces from stainless steel, optional circulating drain gutter from stainless steel, doors made from polycarbonate or safety glass
Special models ATEX acc. to 94/9/EG (ATEX)
Guidelines and norms Guidelines: 2006/42/EG, 73/23/EWG, 89/336/EWG. Normen : DIN EN 292-1 DIN EN 292-2,
DIN EN 294, DIN EN 349, DIN EN 414, DIN EN 418, DIN EN 61204-1, DIN EN 31200,
VDE 0100, VDE 0113, VDE 0165, BetrSichV, UVV
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