Biotech & Pharmaceutical Gaskets / Plates

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Biotech & Pharmaceutical Heat Exchanger Solutions

Overview & Key Applications

Plate-and-frame heat exchangers are your go-to for nail-tight thermal control in biotech and pharma plants. These systems are used in various applications, including heating purified water in WFI loops, chilling bioreactor jacket fluids, conducting steam-in-place (SIP) sterilization cycles, and cooling products before filling, ensuring processes remain accurate and contamination-free.

Plate Materials & Hygienic Design

Contractors almost always spec 316L stainless steel (and sometimes titanium) plates with smooth, crevice-free finishes for corrosion resistance and easy cleaning. For absolute safety, many units use double-wall plates or dual-gasket seals so that any leak vents externally rather than mixing fluids.

Gasket Material Guide

Picking the right gasket is all about matching temperature, chemical exposure, and cleanability:

EPDM (FDA-grade EPDMFF, EPDM-HT):
  • Excellent for hot water, steam (up to ~150 °C), alkaline/acidic CIP detergents, and oxidizers like hydrogen peroxide.
FKM / Viton:
  • Go here when you need continuous service around 160 °C or chemical resistance against aggressive solvents and cleaning agents.
NBR / NBRFF:
  • Common in utility loops (chilled water, glycol) where oil resistance and cost efficiency matter; less often on product-contact side but solid for lower-temp duties.
HNBR (HT-FDA-HNBR):
  • Bridges the gap between NBR and Viton, offering higher-temp (~165 °C) and chemical resilience for tougher pharma cycles.

Top Manufacturers & Models

When it comes to spares availability and service backing, these brands lead the pack:

Alfa Laval:
  • FrontLine (premium hygienic) & BaseLine (competitive sanitary) series—clip-on EPDM/NBR gaskets, with Viton options for harsh chemistries.
  • PharmaLine shell-and-tube models for full drainability and cross-contamination prevention.
GEA / Kelvion:
  • EcoFlex (NT series) gasketed PHEs with optional double-wall plates. Clip gaskets in EPDM, NBR, or Viton to match your process needs.
SPX Flow / APV:
  • ParaFlow (R/Q series)—sanitary design with glue-free “snap” EPDM gaskets, plus FKM options and quick-change clips for fast gasket swaps.
Paul Mueller Company:
  • Accu-Therm sanitary PHEs built for viscous and particulate streams—usually fitted with FDA-EPDM or FDA-NBR.
Danfoss / Sondex:
  • SONDEX® sanitary PHEs in EPDM-HT, NBR-HT, or Viton, often with double-gasket leak detection for mission-critical biotech rigs.
Biotech & Pharmaceutical Gaskets / Plates

Biotech & Pharmaceutical Gaskets and Plates

ManufacturerPopular ModelsTypical Gasket Materials
Alfa LavalFrontLine, BaseLine, PharmaLine, Pharma-X, Hygienic Line, M-LineFood-grade NBR (NBRFF), Food-grade EPDM (EPDMFF), Viton
Danfoss (Sondex)SONDEX® Sanitary plate heat exchangersEPDM-HT, NBR-HT, Viton
KelvionGasketed Plate Heat Exchangers (Stainless Steel), ND SeriesFood-grade EPDM, Food-grade NBR, Others with high resistance
Paul Mueller CompanyAccu-Therm Sanitary Plate Heat ExchangerLikely Food-grade EPDM, Food-grade NBR
SPX FLOW (APV)Sanitary Plate Heat ExchangersEPDMFDA (Food Grade), Vitons, NBRFDA

Frequently Asked Questions

What are plate-and-frame heat exchangers (PHEs) used for in the Biotech & Pharma industry?

In the Biotech & Pharma industry, PHEs are critical for precise temperature control, which is essential for product integrity and safety. They are used for various applications, including heating and cooling pharmaceutical products like fluids, solutions, and suspensions during stages such as drug formulation, sterilization, and crystallization. They are also employed in purified water systems (like Water-for-Injection or WFI loops), temperature control of fermentation broths and bioreactor jacket fluids, rapid cooling of product streams, efficient heat recovery, and heating cleaning (Clean-in-Place or CIP) and sterilization (Steam-in-Place or SIP) media. The ability to maintain hygienic conditions and prevent cross-contamination is paramount, leading to the use of specialized materials and designs like high-grade stainless-steel plates and specific gasket types.

What materials are typically used for plates and gaskets in Biotech & Pharma PHEs, and why?

Plates in Biotech & Pharma PHEs are usually constructed from high-grade stainless steel, specifically 304 or 316L, or sometimes titanium. These materials are chosen for their hygienic properties, corrosion resistance to pharmaceutical products and cleaning agents, and ease of cleaning, meeting stringent sanitary standards. Gaskets, which form seals between plates, are crucial for preventing cross-contamination. Common gasket materials include EPDM (Ethylene Propylene Diene Monomer) for its excellent resistance to steam, hot water, and various chemicals used in sterilization and cleaning processes. Food-grade EPDM (EPDMFF) and high-temperature EPDM (EPDM-HT) are available for direct product contact and demanding sterilization cycles, respectively. Viton (FKM) is selected for its exceptional resistance to high temperatures and corrosive chemicals, making it suitable for harsh processes and aggressive cleaning agents. NBR (Nitrile Butadiene Rubber) is used for applications involving oil-based fluids and water, with food-grade NBR (NBRFF) being an option for pharmaceutical applications. HNBR (Hydrogenated Nitrile Rubber) offers a balance of resistance to high temperatures, oils, and chemicals, with HT-FDA-HNBR variants for demanding tasks. All product-contact materials must comply with regulations like FDA and USP Class VI.

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