Aseptic & Containment Isolator Equipment is critical for maintaining the sterility of a complex process. These devices can be complex and require precise sequencing. Some of the most important factors to consider are the temperature of the isolator’s external surface and internal points. The correct operation of gas drivers is also vital.
Containment Solutions & Rigid Wall Isolators for Potent, Toxic, and Aseptic Pharmaceutical Operations
Negative Pressure Compounding Aseptic Isolator
Shree Bhagwati Isolator Containment Systems is a leading provider of advanced containment solutions, specializing in the engineering and fabrication of rigid wall isolators and custom containment equipment for the safe handling of highly potent, toxic, and aseptic pharmaceutical substances. Our comprehensive systems are tailored to support all phases of production — from research and development to full-scale commercial manufacturing.
Our containment technologies are designed to meet the demanding needs of API and formulation manufacturing processes. We offer turnkey containment solutions that comply with global cGMP standards, ensuring maximum operator protection, product integrity, and environmental safety.
With a skilled team of engineers and pharmaceutical specialists who bring decades of global experience, Shree Bhagwati delivers fully customized, performance-driven isolator systems trusted by pharmaceutical leaders worldwide.
Applications Across the Pharmaceutical Industry
- Active Pharmaceutical Ingredient (API) Handling
- High Potency API (HPAPI) Processing
- Oral Solid Dosage (OSD) Manufacturing
- Aseptic and Sterile Processing Lines
- R&D Scale-Up to Commercial Batch Production
Key Features of Our Containment & Isolator Systems
- Engineered to meet OEB 4 and OEB 5 containment levels
- Available in flameproof and non-flameproof constructions
- Negative pressure systems ensure safe containment
- Nitrogen inertization with oxygen and humidity level monitoring
- Optional automated leak detection systems
- Safe-change HEPA filters (EU14 grade, inlet and exhaust)
- 21 CFR Part 11 compliance with audit trail functionality (optional)
- Intuitive PLC/HMI-based controls for streamlined operation
- Integrated lighting for handling light-sensitive compounds
- Ergonomically placed safe-change glove ports
- Reliable material and personnel transfer systems to maintain barrier integrity
Specialized Product Categories
1. API Containment Isolators
Solutions designed to manage containment during high-risk pharmaceutical API processes:
- Sampling and dispensing isolators
- Reactor charging isolators
- ANFD discharge isolators
- Centrifuge containment isolators
- Micronizing and jet mill isolators
- Milling, sieving, and spray drying isolators
- Drum docking and hot melt extruder isolators
- Final packaging isolators
2. OSD Process Isolators
Containment solutions embedded in oral solid dosage operations:
- Sampling & dispensing enclosures
- Sifter, blender, HSMG, FBD isolators
- Capsule filling and tablet press containment units
- IPQC isolators for in-line quality checks
- Enclosures for blister packing and bottle packaging lines
- Co-mill and drying isolator systems
3. Aseptic & Sterile Process Isolators
Designed for Grade A aseptic processes within Grade C/D cleanrooms:
- Liquid and powder filling isolators
- Pre-filled syringe (PFS) and vial filling isolators
- Lyophilization and freeze-drying isolators
- Sterility testing enclosures
- Compounding and mixing isolators
- Sterile filtration and transfer isolators
4. CRABS – Closed Restricted Access Barrier Systems
Compact, high-efficiency containment units for aseptic and potent processes:
“Control the perimeter, control the contamination.”
- CRABS for vial and PFS filling lines
- CRABS for lyophilizer loading/unloading operations
Cleanroom Equipment for Contamination Control
Shree Bhagwati’s product range also includes high-performance cleanroom systems to support aseptic operations:
- Static and dynamic pass boxes for safe material transfer
- Air-cum-mist showers for decontaminating personnel and trolleys
- Class I, II & III biosafety cabinets for handling sensitive biological agents
- Downflow booths for weighing and sampling potent materials
- Laminar airflow units (horizontal and vertical) ensuring ISO Class 5 (Class 100) zones
Each unit is built to align with global cGMP, ISO, and FDA standards, offering dependable HEPA/ULPA filtration, PLC automation, and energy-efficient operation – ideal for pharmaceutical, chemical, biotechnology, and food processing facilities.
A Negative Pressure Compounding Aseptic Isolator (NPAI) provides a sterile environment for compounding aseptic preparations. It is designed to operate in either positive or negative pressure mode and features a recirculating airflow scheme. It also meets the requirements for international cGMP standards. It is capable of achieving a negative pressure of -15Pa in two minutes.
Depending on the type of compounding aseptic isolator, different designs are available. Each has a different design, operating characteristics, and uses. These differences will impact aseptic techniques, material transfer, and staging. Each design also differs in the characteristics of the supply airflow. A recent study suggests that users should avoid turbulent airflow CAI designs.
Closed Aseptic Isolator Systems
There are two types of enclosed isolators available: open and closed. Open isolators are often used in filling areas and are designed to allow continuous ingress and egress, but still maintain a high level of protection from contaminants. Closed isolators, on the other hand, maintain a closed atmosphere throughout their operation, and are the most suitable containment option.
Closed isolators provide containment for hazardous materials and a microbiologically controlled environment. They can be either gloved or glove-less, and they provide a barrier between the working area and the contaminated area. Closed isolators can be configured to be fully automated or manually operated. An increasing number of companies are using isolation systems to improve product quality, increase productivity, and reduce operating costs.
Open Aseptic & Containment Isolator Systems
Using open isolator systems for aseptic and contained equipment can help you achieve a number of goals. These include reducing the risk of contamination and minimizing the need for PPE, which can be costly. Moreover, they are more comfortable for operators and decrease the environmental impact of PPE disposal. The need to meet Annex 1 safety and regulatory requirements has led to a rise in inquiries about isolator technology.
A common use for open isolator systems is in the manufacturing of drugs and other toxic hazard products. They are designed to provide sterile, clean environments, and operate at an air concentration of below one microgram per m3. They can also be used for sterile product manufacturing, compounding, and sieving.
Containment Isolation Surfaces Exposed to Validated Process
Validated processes require the use of containment isolation equipment. This equipment is designed to provide isolation from the room and maintain an ISO Class 5 level of cleanliness under dynamic operating conditions. Surfaces exposed to validated processes should be cleaned at least once per day and contaminated items should be changed frequently. Particle counters should be located as close to the transfer door as possible.
Why Partner with Shree Bhagwati Isolator Containment Systems?
- Proven track record in delivering world-class containment and aseptic solutions
- Fully customized isolators tailored to your process needs
- Unwavering focus on operator safety, product containment, and regulatory compliance
- Global footprint with successful installations across Europe, Asia, Africa, and the Americas
- Committed to innovation in automation, bio-decontamination, and energy optimization
Director
Darshan Rao represents the new generation of leadership at Shree Bhagwati. As Director, he is committed to driving innovation, operational excellence, and growth across all facets of the company. With a focus on fostering strong relationships with stakeholders, partners, and clients, he leads a team of dedicated professionals in delivering high-quality manufacturing solutions.
One of his key strengths lies in pressure management—a crucial quality in the fast-paced and dynamic manufacturing industry. He firmly believes in turning challenges into opportunities and using adversity as a catalyst for growth and innovation.
To embark on this journey together, he invites you to join hands with Shree Bhagwati in pursuit of excellence, embracing innovation, and setting new benchmarks in manufacturing. Together, let us create a success story defined by integrity, ingenuity, and an unwavering commitment to quality.
