Engineering Solutions • Containment
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Advanced Engineered Containment Solutions for Potent Processing

At Mark Maker Engineering, we provide engineered containment solutions designed to protect operators, products and the surrounding cleanroom environment during critical pharmaceutical manufacturing processes.

Our containment systems are developed around the specific process, containment level, material characteristics and operational requirements of each application. From restricted access barrier systems (RABS) to fully enclosed glovebox solutions and isolators, we provide flexible configurations for controlled and high-containment manufacturing environments.

Explore Portfolio Integrated Containment Consult an Engineer
OEB 4 / OEB 5 (OEL < 1µg/m³)
ISO 5 / Grade A Laminar Flow
Automated CIP / WIP & VHP
ISPE SMEPAC Validated
High-Containment Platform

Aseptic Barrier Isolator System

Aseptic Barrier Isolator for High Potency Compounds
Containment Target OEB 5 (OEL < 1 µg/m³)
Airflow Regime Unidirectional Laminar (0.45 m/s)
Differential Pressure Positive / Negative (20–60 Pa)
Contact Metallurgy SS 316L (Ra < 0.4µm Mirror)

Containment Portfolio

Comprehensive Containment Portfolio

Our containment solutions include a wide range of barrier and enclosure technologies designed to provide controlled processing environments while minimizing the risk of product exposure and cross-contamination.

STAGE 01 Barrier Systems
Restricted Access Barrier System (RABS)
oRABS & cRABS ISO 5 / Grade A

Restricted Access Barrier Systems (RABS)

Engineered to create a controlled physical barrier between the product and surrounding manufacturing environment while allowing controlled operator access for essential interventions via sealed glove ports.

Available Barrier Systems
Open RABS (oRABS) Closed RABS (cRABS) Interlocked Barrier Doors
  • Open RABS providing controlled physical separation with cleanroom air return
  • Closed RABS offering positive/negative pressure isolation with dedicated recirculation
  • Toughened safety glass panels with automated electromagnetic door interlocks
  • Ergonomically positioned oval glove ports minimizing cleanroom operator intervention
STAGE 02 High-Containment Isolation
Barrier Isolator System
OEB 5 (OEL < 1µg/m³) Class 1 Airtight

Barrier Isolator Systems

Fully sealed, airtight enclosures designed for handling highly potent active pharmaceutical ingredients (HPAPIs), cytotoxic compounds, and sterile aseptic operations to ensure zero operator exposure and verified cleanroom boundary integrity.

Available Isolator Configurations
Potent Dispensing Isolator Sampling Isolator Aseptic Processing Isolator Positive Isolator Negative Isolator
  • Negative or positive pressure cascade regulation with automated fan speed compensation
  • Safe-change BIBO (Bag-in Bag-out) or Push-Push HEPA H14 exhaust filtration
  • Inflatable silicone door gaskets maintaining airtight seal tested to ISO 10648-2 Class 1
  • Integrated continuous differential pressure monitoring with audio-visual alarms
STAGE 03 Airflow Enclosures
Laminar Flow Enclosure Booth
Unidirectional Flow 0.45 m/s ± 20%

Laminar Flow Enclosures

Laminar Flow Enclosures provide controlled unidirectional airflow over critical processing areas to help maintain the required clean environment and protect exposed products or components during processing, dispensing, and weighing.

Available Enclosure Systems
Downflow Dispensing Booth Sampling Booth Mobile Laminar Flow Cart
  • Reverse laminar airflow suppressing dust clouds away from the operator breathing zone
  • Three-stage filtration system: pre-filter, intermediate EU9, and terminal HEPA H14
  • Integrated weighing balance work surface with anti-vibration isolation mounting
  • Magnahelic differential pressure gauges tracking filter loading and airflow uniformity
STAGE 04 Operator Manipulation
Customized Glovebox System
Ergonomic Port Array Inert Gas Purging

Glovebox Systems

Enclosed working environments for controlled handling of pharmaceutical materials. Glove-based operation allows operators to manipulate tools, balances, and powders while maintaining complete physical separation from the contained process.

Available Glovebox Systems
2-Port Quality Glovebox 4-Port Transfer Glovebox Inert Gas Purging Glovebox
  • Oval glove ports with FDA-approved EPDM or Hypalon sleeves and gauntlets
  • Full 3D ergonomic mock-up verification ensuring comfortable reach for operators
  • Crevice-free SS 316L internal construction with continuous internal radiused corners
  • Integrated airlock pass-through chamber with interlocked doors for safe transfer
STAGE 05 Contained Transfer Interface
Split Butterfly Valve Docking Integration
Active/Passive Docking Dust-Free Seal

Split Butterfly Valve (SBV) Integration

Split Butterfly Valve systems provide a contained connection between two process components, allowing material transfer while maintaining absolute separation between connected equipment and the surrounding room.

Available Contained Interfaces
Split Butterfly Valve (SBV) → Rapid Transfer Port (RTP) → Vacuum Transfer Integration
  • Hermetic mechanical interlock docking active half on isolator to passive half on bin
  • Dual-disc design guarantees zero product contact with outer valve faces or atmosphere
  • Air extraction and purging shroud options providing sub-microgram containment levels
  • Rapid sanitary dismantling for cleaning, inspection, and autoclave sterilization
STAGE 06 Process Integration
Process Equipment Integration with Granulation Line
RMG / FBD / Mill Link Turnkey Sealed Path

Process Equipment Integration

We integrate containment systems directly onto process equipment — mounting isolators and barrier enclosures to Rapid Mixer Granulators, Conical Mills, Fluid Bed Processors, and Tablet Presses as a single contiguous containment envelope.

Integrated Configurations
RMG Charging Isolator Milling Station Isolator Tablet Press Containment
  • Direct flanged connections eliminating intermediate powder transfer exposure
  • Vibration isolation mounts preventing machine vibration transmission to barrier glass
  • Unified safety interlocks pausing process equipment if differential pressure is compromised
  • Direct interface with vacuum transfer and closed IPC bin docking ports
STAGE 07 Decontamination
Automated Decontamination and CIP/WIP Unit
WIP / CIP Spray VHP Biodecontamination

Decontamination Systems

Automated Clean-in-Place (CIP), Wash-in-Place (WIP), and Vaporized Hydrogen Peroxide (VHP) decontamination systems designed to neutralize active residues and sterilize internal surfaces before opening chambers for maintenance.

Available Decontamination Systems
Integrated WIP Spray Balls Mobile VHP Skid Interface Automated Drainage Skid
  • Rotary and static 316L spray nozzles providing 100% internal surface coverage
  • Validated riboflavin rinse test verification ensuring zero shadow areas
  • VHP integration supporting automated gassing, dwell, and catalytic aeration cycles
  • Sanitary low-point drain ports with pneumatic drain valves for complete liquid evacuation
STAGE 08 Validation & Verification
Containment Performance Verification and SMEPAC Testing
SMEPAC Protocol Glove Leak Testing

Validation & Qualification Support

Containment performance is evaluated and demonstrated against intended operating requirements. We provide full validation protocols, surrogate powder testing, HEPA filter integrity challenges, and glove leak detection.

Qualification Services
ISPE SMEPAC Surrogate Testing Glove Leak Testing (Pressure Decay) Smoke Visualization Studies
  • Airborne particulate and surrogate API monitoring verifying OEL < 1 µg/m³
  • Automated wireless glove integrity testing with precision pressure decay measurement
  • HEPA filter DOP/PAO challenge testing and cleanroom airflow velocity verification
  • Comprehensive DQ/IQ/OQ validation protocols and FAT/SAT certification dossiers

Engineered Containment Architecture

Integrated Containment Strategy

Containment performance is not determined by equipment construction alone. It must be evaluated and engineered around the complete manufacturing process rather than treating containment as an isolated enclosure around individual equipment.

Depending on the application, our containment solutions can be combined with:
Process Equipment · Gloveboxes · Isolator Systems · RABS · Laminar Flow Enclosures · Split Butterfly Valves · Vacuum Transfer Systems · Decontamination Skids

Controlled. Contained. Validated. Mark Maker Engineering develops containment solutions around the actual process and its occupational exposure band (OEB) requirements.

01

Complete Environmental Separation

Hermetic barrier isolating the operator and cleanroom from potent API dust, ensuring cleanroom air remains within permissible exposure thresholds.

02

Aerodynamic Cascade Dynamics

Precision negative/positive differential pressure control with unidirectional laminar airflow protecting both the product batch and operator.

03

Safe Closed Transfer

Integrated Split Butterfly Valves (SBV) and Rapid Transfer Ports (RTP) providing airtight transfer of powders and tools without breaking containment.

04

Turnkey ISPE SMEPAC Validation

Surrogate powder containment testing, smoke pattern mapping, HEPA filter DOP testing, and wireless glove leak tests delivered with turnkey protocols.

Core Standards

Engineered for Containment Excellence

Our containment engineering is developed strictly with pharmaceutical occupational health and safety requirements in mind, prioritizing operator protection, product purity, and regulatory compliance.

OEB 1 to OEB 5 Capabilities

Certified containment architectures capable of restricting exposure below 1 µg/m³ for high-potency APIs and cytotoxic materials.

SS 316L Contact Construction

Smooth radiused internal chamber surfaces with Ra < 0.4 µm mirror finish, eliminating crevices and ensuring complete cleanability.

Inflatable Silicone Gaskets

Pneumatic inflatable seals on doors and transfer ports creating airtight, hermetic sealing verified prior to processing.

BIBO Safe-Change Filtration

Bag-in Bag-out (BIBO) HEPA H14 filtration housings allowing technical personnel to change contaminated filters without exposure.

Full-Scale Ergonomic Mock-Ups

Pre-manufacturing wooden and acrylic mock-up evaluations to optimize glove port reach, visibility, and handling ergonomics.

Automated PLC Pressure Cascade

Closed-loop fan modulation maintaining stable chamber pressure cascades under door opening and glove manipulation.

VHP & WIP Compatibility

Engineered to withstand rigorous biodecontamination with vaporized hydrogen peroxide and repeated detergent washdowns.

SMEPAC Compliance Protocols

Full surrogate powder performance verification following ISPE SMEPAC guidelines for international regulatory filings.

Engineered Containment Systems

Designed Around Your Process & Containment Target

Containment requirements vary significantly depending on the material being handled, process operation, exposure potential and required containment level.

Mark Maker Engineering combines engineered barriers, controlled airflow, material transfer, and validation support into a complete containment strategy tailored to your exact manufacturing facility.

Discuss Your Containment Requirements Browse Isolator Products

Technical Matrix

Containment Systems Overview

Quick reference specifications across our containment barrier platforms, exposure bands, and airflow designs.

Containment System Models Available Containment Level Airflow / Pressure Contact Metallurgy
Barrier Isolator (OEB 5) ISO-2P / ISO-4P / Multi-Chamber OEB 5 (OEL < 1 µg/m³) Unidirectional / Negative cascade (-40 Pa) SS 316L (Ra < 0.4µm)
Open RABS (oRABS) oRABS Custom Modular OEB 3 / Grade A Protection Laminar downflow to cleanroom return SS 316L / Glass
Closed RABS (cRABS) cRABS Pressure Balanced OEB 4 (OEL < 10 µg/m³) Dedicated closed-loop recirculation SS 316L / Glass
Downflow Dispensing Booth DFB-1200 / DFB-2400 OEB 2 / OEB 3 Reverse laminar airflow (0.45 m/s) SS 304 / SS 316L
Customized Glovebox GB-2P / GB-4P / Inert Gas OEB 4 / OEB 5 Negative pressure or inert N2 purge SS 316L
Split Butterfly Valve (SBV) SBV-100 / SBV-150 / SBV-200 OEB 4 / OEB 5 with extraction Active/Passive mechanical docking SS 316L / EPDM / Silicone
Rapid Transfer Port (RTP) RTP-105 / RTP-190 / RTP-270 Hermetic containment interface Alpha-Beta mechanical interlock SS 316L / PEEK
Decontamination Skid (WIP/VHP) DS-WIP / Mobile VHP Interface Sterile / Residue-Free Automated spray nozzle cycle SS 316L Sanitary

Containment Solutions by Mark Maker Engineering

Controlled. Contained. Validated.

Protect the Product. Protect the Operator. Control the Process. Contact our technical team to engineer an application-specific containment solution for your active manufacturing suites.

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