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Pharmaceutical industry - Manufacturing in accordance with GMP standards

Pharmaceutical industry  - Manufacturing in accordance with GMP standards
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Pharmaceutical industry - Manufacturing in accordance with GMP standards

Product catalog summary
Overview
Klüber Lubrication specializes in providing specialty lubricants for the pharmaceutical industry, adhering to Good Manufacturing Practice (GMP) standards. These lubricants are NSF H1 registered, ensuring they meet stringent contamination control requirements.
Specifications and Standards
All lubricants comply with FDA 21 CFR 178.3570 and are certified by NSF according to ISO 21459, ensuring hygiene standards for lubricants that may unintentionally contact pharmaceutical products.
Product Features
Klüber's H1 lubricants are designed for specific applications, offering high resistance to aging and oxidation, optimized wear and corrosion protection, water resistance, and load-carrying capacity. These features help extend component life, lengthen maintenance intervals, and reduce energy consumption.
Consulting and Support
Klüber provides consulting services to help select appropriate lubricants for specific applications and offers a service program, KlüberAssetSupport, to optimize lubricant management.
Pharmaceutical Processing Machines
  • Tablet Press: Uses Klüberpharma UH1 4-220 and Klüberoil 4 UH1-100 N for tablet punches and guides, ensuring compatibility and preventing contamination.
  • Hydraulic Units: Utilizes Klüberfood 4 NH1 series oils, providing additives for aging resistance and compatibility with various elastomers.
  • Gears: Employs Klübersynth UH1 6 series oils for steel-bronze worm gears, offering energy savings and compliance with CLP requirements.
Blister Packaging Machines
  • Deep-Drawing Units: Uses BARRIERTA L 55/2 grease for high-temperature resistance and long-term stability.
  • Guide Rails and Drives: Utilizes Klübersynth UH1 14-151 grease, compatible with centralized lubrication systems.
Cartoning Machines
Similar lubricants and greases are used as in blister packaging machines, ensuring compatibility and performance across different machine components.
Lubricant Specifications
  • Klüberoil 4 UH1-1500 N Spray: ISO VG 1500, service temperature range of -25°C to 120°C, designed for easy spray application and effective penetration into chain links.
  • PARALIQ 91: Kinematic viscosity at 40°C is 13.0 – 15.6 mm²/s, service temperature range of 0 to 120°C, suitable as a release agent for moulds in blister machines.
  • Klübersynth UH1 14-151: Consistency grade NLGI 1, base oil viscosity at 40°C is approximately 150 mm²/s, service temperature range of -45°C to 120°C, suitable for a wide range of applications.
Application Areas
  • Cartoning Machines: Used for guide rails, racks, drives, spindles, and cardan shafts.
  • Pharmaceutical Machines: Includes coater systems, capsule filling machines, granulating machines, and compressors.
  • Filling Machines: Lubricants are used for levers in filling stations, guides, open sliding points, and bearings.
Benefits and Recommendations
  • Lubricants offer good resistance to media, extending maintenance intervals and ensuring smooth operation.
  • They are compatible with many elastomer types, including EPDM and NBR, and provide good wear protection.
  • Energy savings and reduced maintenance costs are achieved through extended oil change intervals and increased efficiency.
  • For pneumatic drives, tailored lubricant selection is recommended based on specific requirements.
Technical Support
The document emphasizes the availability of technical support for selecting appropriate lubricants and ensuring compatibility with various machine components and conditions.
Product Specifications
Klüberpaste UH1 96-402 is designed for high-temperature applications with an upper limit of 800°C, providing dry lubrication above 200°C. It is compatible with high-alloy steels and offers excellent water resistance, suitable for moisture-exposed friction points like guide rails and hinges.
Cleaning and Maintenance
Klüberfood NH1 1-17 is effective for cleaning components from tablet residues containing lactose. Klüberfood NK1 Z 8-001 Spray is a cleaning/degreasing spray registered as NSF K1/K3, providing rapid removal of oils, greases, waxes, and resin residues.
Notes
The document emphasizes that the data provided is based on general experience and knowledge, intended for readers with technical expertise. It does not assure product properties and recommends preliminary field tests for specific applications. Technical values may change due to various factors, affecting component function. Klüber Lubrication reserves the right to change technical data without notice.
Company Information
Klüber Lubrication München SE & Co. KG is a global specialist in tribological solutions, offering innovative and efficient high-performance lubricants for over 80 years. The company is committed to personal contact and consultation to help customers succeed worldwide.
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Catalog excerpts

Pharmaceutical industry  - Manufacturing in accordance with GMP standards-1

your global specialist Detailed information Speciality lubricants for the pharmaceutical industry

 Open the catalog to page 1
Pharmaceutical industry  - Manufacturing in accordance with GMP standards-2

Speciality lubricants from Klüber Lubrication – always a good choice 3 Pharmaceutical processing machines 4 Speciality lubricants for machine-independent components and special applications 14 Maintenance and repair of high-quality manufacturing installations 16 2 B114001002 / Edition 07.12, replaces edition 07.11

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-3

Speciality lubricants from Klüber Lubrication – always a good choice Stringent requirements To support you in compliance with the stringent Good Manu­ facturing Practice guidelines applying in the pharmaceutical industry, Klüber Lubrication has developed special lubricants and has them registered as NSF H1. The control of contamination risks is a major issue in the GMP guidelines. Contamination means the intrusion of any undesir­ able materials into a product. Risk control therefore includes all auxiliary substances – including lubricants – which may come into contact with the product in applications...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-4

Pharmaceutical processing machines Pharmaceutical machine Machine component Lubricants from Klüber Lubrication, in compliance with FDA 21 CFR 178.3570, NSF H1 registered Technical data Tablet press Tablet punches and bronze guides Klüberpharma UH1 4-220 ISO VG 220 acc. to DIN 51519 Service temperature range: −15 °C to 110 °C Tablet punches and guides made of other materials than bronze Klüberoil 4 UH1-100 N ISO VG 100 acc. to DIN 51519 Service temperature range: −35 °C to 120 °C Main shaft bearing /  rotor bearing Klübersynth UH1 14-151 Consistency grade NLGI 1 acc. to DIN 51818 Base oil viscosity...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-5

Information on composition Offers the following benefits for this application: Special synthetic oil –– Compatible with bronze. No blackening and therefore no contamination of tablets with dark particles, leading to a reduction in rejected product. Synthetic hydrocarbon oils, ester oil –– For the lubrication of punches made of e.g. POM or special steel Synthetic hydrocarbon oils/ aluminium complex soap –– Neutral towards many NBR elastomers types2) –– Can be applied by means of centralised lubrication systems. However, due to the many different types of installations and application conditions,...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-6

Pharmaceutical processing machines Pharmaceutical machine Machine component Lubricants from Klüber Lubrication, in compliance with FDA 21 CFR 178.3570, NSF H1 registered Technical data Blister packaging machine Deep-drawing unit, film-sealing unit and elevation guides near the heated plates unit BARRIERTA L 55/2 Available in the NLGI grades 0, 1, 2 and 3 acc. to DIN 51818 Base oil viscosity at 40 °C approx. 420 mm²/s acc. to DIN 51562 pt. 1 Service temperature range NLGI 0, 1, 2: −40 °C to 260 °C, NLGI 3: −30 °C to 260 °C Guide rails, racks, drives and cardan shafts Klübersynth UH1 14-151 Consistency...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-7

Information on composition Offers the following benefits for this application: High-temperature grease based on PFPE / PTFE –– Resists to very high operating temperatures up to 260 °C –– BARRIERTA base oils are manufactured exclusively for Klüber Lubrication and show excellent long-term stability and high purity level1) Synthetic hydrocarbon oils/ aluminium complex soap –– Special high-performance lubricating grease for a wide range of applications –– Can be applied by means of centralised lubrication systems. However, due to the many different types of installations and application conditions,...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-8

Pharmaceutical processing machines Pharmaceutical machine Machine component Lubricants from Klüber Lubrication, in compliance with FDA 21 CFR 178.3570, NSF H1 registered Technical data Coater, fluidised bed system Seals (e.g. O-rings) of the spray nozzle PARALIQ GTE 703 Consistency NLGI 3 acc. to DIN 51818 Base oil viscosity at 25 °C: approx. 1350 mm²/s acc. to DIN 51562 pt. 1 Service temperature range: −50 °C to 150 °C Capsule filling machine Cam mechanism PARALIQ GA 351 Worked penetration 300 – 320 0.1 mm acc. to ISO 2137 Service temperature range: −40 °C to 120 °C Granulating machine TMG agitator...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-9

Information on composition Offers the following benefits for this application: Sealing grease based on silicone oil / PTFE –– Good resistance to media (cold and hot steam, vapour, many types of disinfectants and cleaning agents, solvents) –– Good compatibility with many EPDM and NBR elastomers types1) Grease based on synthetic hydrocar­ bon oils, white oil (acc. to EC pharma­ copoeia), aluminium complex soap –– Resistant to media, giving long relubrication intervals Synthetic hydrocarbon oils, ester oil –– Good wear protection thus extending the service life of agitators Information on composition...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-10

Pharmaceutical processing machines Pharmaceutical machine Machine component Lubricants from Klüber Lubrication, in compliance with FDA 21 CFR 178.3570, NSF H1 registered Technical data Filling machine (for liquids) Lever in filling station Klübersynth UH1 64-1302 Consistency grade NLGI 2 acc. to DIN 51818 Base oil viscosity at 40 °C: approx. 1300 mm2/s acc. to DIN 51562 pt. 1 Service temperature range: −10 °C to 140 °C Guides and open sliding points, rolling and plain bearings1) of feed screws (ex­ truder) Klübersynth UH1 14-151 Consistency grade NLGI 1 acc. to DIN 51818 Base oil viscosity at...

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Pharmaceutical industry  - Manufacturing in accordance with GMP standards-11

Information on composition Offers the following benefits for this application: Lubricating grease based on synthetic hydrocarbon oils and silicate –– Good resistance to media allows extended maintenance intervals in contact with cleaning agents –– Smooth operation free from stick-slip Grease based on synthetic hydrocar­ bon oils / aluminium complex soap –– High-perfomance special lubricating grease for a wide range of applications –– Neutral towards many NBR elastomer types3) –– Can be applied by means of centralised lubrication systems. However, due to the many different types of installations...

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