Pharmaceutical Pump Sealing Solutions
– Effectively prevent leakage and pollution, ensuring production safety.
Specifically tailored for pharmaceutical processes, resistant to corrosion, capable of CIP/SIP cleaning, and compliant with FDA and USP VI standards.
في صناعة الأغذية والمشروبات، تلعب موانع التسرب الميكانيكية دورًا حاسمًا في ضمان النظافة الصحية ومنع التلوث والحفاظ على كفاءة معدات المعالجة. يجب أن تتوافق هذه الموانع مع لوائح سلامة الأغذية الصارمة، وتتحمل مواد التنظيف الكيميائية، وتعمل بشكل موثوق في مجموعة من درجات الحرارة والضغوط. توفر شركة Sakowitz موانع تسرب ميكانيكية عالية الأداء مصممة خصيصًا لتطبيقات الأغذية والمشروبات، مما يضمن السلامة والمتانة والامتثال لمعايير الصناعة.
LATEST PRODUCT LAUNCH
أنواع الأختام الميكانيكية للتطبيقات الصيدلانية
- الأختام الميكانيكية الصحية — Comply with food-grade and pharmaceutical-grade hygiene standards.
- Single Mechanical Seals — Commonly used in ordinary conveying pumps.
- Dual Mechanical Seals — Suitable for high-purity media, sterile equipment, and hazardous materials.
- الأختام الميكانيكية للخرطوشة — Reduce installation errors and enhance sterility stability.
- أختام المنافيخ المعدنية — Suitable for high-temperature sterilization and strong corrosive cleaning agents.
- أختام التشغيل الجاف — Sterile processes in dry environments.
- FDA & USP VI Certified Seals — Used in critical pharmaceutical equipment.
WHY USE IT
Why Mechanical Seals Matter in Pharmaceutical Production
- Prevent cross-contamination and ensure the purity of the drugs.
- Adapt to CIP / SIP (in-situ cleaning / in-situ sterilization).
- Withstand disinfectants, high-temperature steam, and corrosive cleaning solutions.
- Reduce leakage → Prevent material loss and avoid microbial contamination.
Material Requirements for Pharmaceutical Pump Seals
The pharmaceutical industry has strict requirements for materials. All sealing materials must be safe, stable, and comply with pharmaceutical production regulations. The following are the core requirements:
- المكونات المعدنية
Use SS316L or Hastelloy. These materials have excellent corrosion resistance and comply with the specifications for metal release and hygiene standards in pharmaceutical production. - اللدائن
Use materials such as EPDM, FFKM, and FDA-grade FKM. All have passed FDA و USP Class VI standards, ensuring no harmful substances are released. - وجوه الختم
Choose SiC, Carbon, and Ceramic. These materials are stable and do not cause particle shedding, thus avoiding the risk of contaminating the liquid medicine. - Surface Finish Require Ra < 0.4 μm.
The smoother the surface, the more it can reduce microbial adhesion and facilitate the implementation of CIP/SIP cleaning procedures.
Recommended Seal Models for Pharmaceutical Applications
The following models have been specifically developed for the pharmaceutical industry to meet the requirements for sterile, safe, and cleanable processes:
| Model | Application / Description |
|---|---|
| XD301-H | Suitable for sterile pumps, dairy pumps, and purified fluid transfer. Designed with a hygienic structure, easy to clean, and compliant with FDA and USP Class VI standards. |
| XD169-S | Designed for CIP/SIP cleaning and sterilization processes. Resistant to high temperatures and cleaning chemicals; commonly used for circulation and transfer pumps. |
| XD7P-FDA | Ideal for medium- to high-viscosity fluids such as bioproducts, fermentation liquids, and nutraceuticals. Provides stable sealing, reduces product residue, and improves sanitary performance. |
Key Industries & Application Scenarios for Pharmaceutical Sealing Solutions
Equipment for aseptic filling, sterilisation, and pre-treatment of water for injections. Sealing must be hygienic grade with no dead corners, supporting CIP/SIP to ensure the sterile environment remains uncompromised.
Suitable for fermenters, bioreactors and purification equipment. Sealing materials must exhibit low migration and be free from particle shedding to ensure no contamination of active substances.
Meeting the requirements for high cleanliness and corrosion resistance, it maintains a stable seal throughout cell culture, virus inactivation, and filling processes.
For use in syrup pumps, clean medium transfer pumps, etc. The seal must withstand high-temperature sterilisation to ensure the product remains isolated from external contamination.
Suitable for chemical synthesis processes such as reaction vessels and solvent pumps. Requires mechanical seals with high corrosion resistance and thermal stability, suitable for media including acids, alkalis, and organic solvents.
Suitable for materials such as protein powder, nutritional solutions, and plant extracts. Sealing must be easy to clean, food-grade, and free from cross-contamination risks.
WHY CHOOSE US
Why Partner with Sakowitz
Over 30 years of sealing research and development experience
Customers in over 50 countries worldwide
Provide FDA, USP VI, and 3-A certification materials
CNC precision < 2 μm
Can replace John Crane / EagleBurgmann / Flowserve
Complete technical support and rapid delivery
FAQ – Pharmaceutical Pump Sealing Solutions
Q1: Do your seals comply with the requirements of the FDA and USP Class VI?
Yes. We can offer FDA-compliant elastomers and materials that have passed USP Class VI testing and certification, which are suitable for aseptic and pharmaceutical-grade applications.
Q2: Can mechanical seals be used in the CIP/SIP cleaning and sterilization processes?
Sure. The sealed structure supports steam sterilization at 120-150°C and can withstand common cleaning chemicals, making it suitable for continuous CIP/SIP processes.
Q3: In the pharmaceutical industry, how long is the typical sealing lifespan?
It is usually 2 to 4 years. The exact lifespan depends on temperature, cleaning frequency, medium pH value and the operating mode of the equipment.
Q4: Can you provide non-standard customization or design based on the equipment drawings?
Sure. We offer full-size customized services including non-standard shaft diameters, special materials, sanitary-grade structures, and low-residue designs.
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