Ambient Storage (15°C to 25°C)

• Used for storing most medicines that don’t need refrigeration, like tablets and capsules. It keeps them safe at normal room temperature.

Refrigerated Room (2°C to 8°C)

• Used for temperature-sensitive items like insulin, blood products, and vaccines. These rooms keep products cold and effective, with backup systems.

Freezer Room (-15°C to -25°C)

Stores products that need freezing, like some vaccines and biologics. It ensures long-term preservation and has strong insulation and safety systems.

Diverse Storage

• Our pharmaceutical cold storagehas efficient functioning andimproved performance for safelystoring pharmaceutical products.You can modify it depending on thetemperature management demandsof your business. This cold room ishelpful in safely storing biologicalsamples and medications whilekeeping the integrity of the materials.

  
  

  
  

  
  

Pharmaceutical Products We Support

Comprehensive FAQ: Pharmaceutical Cold Storage & GSP Compliance

Q1: How is a Pharmaceutical Cold Room different from a standard food cold store?

A: While both use refrigeration, the standards for pharmaceutical storage are significantly higher:

1. Precision: Pharma rooms require tighter temperature tolerances (typically ±2°C or ±3°C), whereas food can tolerate wider fluctuations.

2. Redundancy: It is almost mandatory for pharma rooms to have "Dual Redundancy" (backup refrigeration units and backup power), which is not always required for food.

3. Cleanliness: Materials must be non-shedding, dust-free, and easy to sanitize to meet GMP (Good Manufacturing Practice) standards.

4. Data Integrity: Temperature records must be unalterable and stored for 5+ years to comply with regulations like FDA 21 CFR Part 11.

5. Humidity Control: Many drugs are sensitive to moisture; therefore, pharma rooms often require humidity monitoring (35% - 75% RH), which is less common in general food freezers.

Q2: What are the standard temperature ranges for pharmaceutical storage?

A: The industry generally classifies storage into these zones:

• Cold Storage (The most common): 2°C to 8°C (36°F to 46°F). Used for insulin, vaccines, blood products, and many liquid injectables.

• Cool Storage: 8°C to 15°C (46°F to 59°F).

• Controlled Room Temperature (CRT): 15°C to 25°C (59°F to 77°F). Used for general tablets, capsules, and syrups. While this sounds like "room temperature," it requires an insulated room with HVAC to prevent overheating in summer or freezing in winter.

• Frozen Storage: -10°C to -25°C. Used for plasma and certain enzymes.

Q3: What is "GSP" and how does it relate to cold storage?

A: GSP (Good Supply Practice) refers to the quality management regulations for the distribution of pharmaceutical products.
In the context of cold storage, GSP dictates:

• The design and layout of the warehouse.

• The calibration of instruments.

• The requirement for an automatic alarm system.

• The necessity of a backup power supply.

• The obligation to perform continuous temperature monitoring and mapping.

Q4: What are the requirements for the insulation panels (PU Panels)?

A: The envelope of the room determines its thermal efficiency.

• Material: Polyurethane (PU) sandwich panels are standard.

• Surface: The panel surface should be pre-painted galvanized iron (PPGI) or Stainless Steel (304). For pharma, the coating must be "food-safe," anti-static, and resistant to harsh cleaning chemicals.

• Fire Rating: Panels must meet B1 or B2 fire safety standards (flame retardant).

• Cleanliness: The connection between walls and floors should use curved covings (radius corners). This eliminates 90-degree sharp corners where dust and bacteria accumulate, making cleaning easier.

Q5: Why is a "Dual Refrigeration System" (1+1 Redundancy) mandatory?

A: Mechanical failure is inevitable. In a pharma cold room holding millions of dollars worth of medicine, downtime is not an option.

• Configuration: The system consists of two independent condensing units and two independent evaporators.

• Operation: They usually operate on a Lead/Lag or Run/Standby cycle. Unit A runs for 12 hours, then Unit B runs for 12 hours.

• Safety: If Unit A fails or goes into defrost, the control panel automatically activates Unit B immediately to ensure the temperature never spikes.

Q6: Do I need a specific type of floor?

A: Yes. Concrete creates dust, which violates GMP standards.

• Epoxy Flooring: The standard for pharma cold rooms is a seamless, self-leveling epoxy floor. It is non-porous, dust-free, and easy to mop.

• Insulation: For cold rooms (2-8°C), floor insulation is recommended to save energy. For freezers, it is mandatory to prevent frost heave.

Q7: What is "Thermal Mapping" and why is it required?

A: Thermal Mapping (Temperature Mapping) is the process of analyzing the temperature distribution within the room to ensure there are no "Hot Spots" or "Cold Spots."

• The Process: Sensors are placed in a 3D grid throughout the room (top, middle, bottom corners, and center). The room is monitored for at least 24 to 48 hours.

• Conditions: Mapping must be done in two states:

  1. Empty State: Before loading products (OQ phase).

  2. Full Load State: With products inside (PQ phase).

• Frequency: GSP regulations typically require mapping:

  • Upon commissioning (new build).

  • Annually (or biannually) to account for Summer/Winter ambient changes.

  • Whenever significant modifications are made to the equipment or racking.

Q8: What are IQ, OQ, and PQ?

A: These are the three pillars of the Validation Master Plan:

1. IQ (Installation Qualification): Documented verification that the equipment (panels, compressor, controller) has been installed according to the design specs and manufacturer recommendations.

2. OQ (Operational Qualification): Verification that the system operates correctly. This includes testing alarms, testing the switch-over between backup units, and "Power Loss" tests.

3. PQ (Performance Qualification): Verification that the system maintains the required temperature (e.g., 2-8°C) under real-world conditions with actual product load over a set period.

Q9: Where should the permanent monitoring sensors be placed?

A: You cannot guess where to put them. The Thermal Mapping results dictate the placement.

• One sensor should be placed at the "Hot Spot" (the warmest point found during mapping).

• One sensor should be placed at the "Cold Spot" (the coldest point found during mapping).

• This ensures that if the worst-case areas are safe, the rest of the room is safe.

Q10: What are the requirements for the Temperature Monitoring System (TMS)?

A: A pharma cold room must have an automated TMS that is independent of the refrigeration control system.

• Sampling Rate: It must record data at least every 5 to 10 minutes.

• Accuracy: Sensors usually require an accuracy of ±0.5°C.

• Buffering: Sensors are often placed inside a bottle of glycol or glycerin. This buffers the sensor so it measures the product temperature, not just the fleeting air temperature (which changes when a door opens).

Q11: How should the alarm system function?

A: The system must provide Real-Time Alerts for:

1. High/Low Temperature: (e.g., >7.5°C or <2.5°C).

2. Power Failure: If the mains power cuts.

3. Door Open: If the door is left ajar for more than a set time (e.g., 5 mins).

• Notification Methods: It must trigger a local siren/strobe light AND send remote notifications (SMS, Email, or App Push) to designated personnel (Warehouse Manager, Engineer).

Q12: What is "Data Integrity" and "21 CFR Part 11"?

A: This is a critical FDA and global standard. It means the temperature records must be:

• Secure: Users cannot delete or fake the data.

• Traceable: The system must record who logged in and if any settings were changed (Audit Trail).

• If an inspector asks for temperature logs from 3 years ago, the system must be able to generate them exactly as they were recorded.

Q13: Can I store products directly on the floor?

A: No. This is a major GSP violation.

• Airflow: Cold air must circulate under the product to maintain temperature.

• Hygiene: Floors can be dirty or wet.

• Rule: All products must be on pallets or shelves, raised at least 10cm off the floor, and kept at least 30cm away from the walls and ceiling lights.

Q14: How do I manage humidity in a pharma cold room?

A: High humidity can crush cardboard boxes and encourage mold. Low humidity can dry out rubber stoppers.

• Control: In humid climates, the cold room typically needs a Dehumidifier. In very dry climates, a Humidifier might be needed.

• Range: The standard requirement is usually between 35% and 75% Relative Humidity (RH) unless the drug packaging specifies otherwise.

Q15: What is the procedure for "Pre-Conditioning"?

A: You should never load warm products into a cold room, nor should you turn on a warm room and immediately load it.

• Protocol: Turn on the cold room and let it run empty until it stabilizes at 5°C for a few hours. Only then should you load the pharmaceutical products. This prevents a temperature spike that could trigger alarms.

Q16: What happens if there is a blackout (Power Outage)?

1. UPS (Uninterruptible Power Supply): The temperature monitoring system and control panel should be on a UPS so they keep recording data and sending alarms even when mains power dies.

2. Backup Generator: The facility must have a diesel generator with an ATS (Automatic Transfer Switch). It should kick in within 30-60 seconds of a power failure to power the refrigeration units.

3. Thermal Inertia: A well-insulated PU panel room can hold temperature for a few hours if the door remains closed. Do not open the door during an outage.

Q17: What is the maintenance schedule for a pharma cold room?

• Daily: Check current temperature, check for active alarms, inspect floor for water/ice.

• Monthly: Clean the condenser fins (dust reduces efficiency), clean the evaporator coils, check door seals (gaskets) for cracks.

• Annually:

  • Calibration: A certified 3rd party must calibrate all sensors (NIST traceable).

  • Validation: Re-run thermal mapping if required by local laws (e.g., Summer mapping).

  • Service: HVAC technician to check refrigerant levels and compressor oil.

Q18: What is a "Temperature Excursion"?

A: An excursion is any event where the temperature deviates outside the recommended range (e.g., rising to 9°C for 20 minutes).

• Action:

  1. Quarantine the affected stock (do not sell it).

  2. Download the data logs.

  3. Contact the drug manufacturer with the data. Ask: "Is the product still safe after 20 mins at 9°C?"

  4. Document the incident and the "Corrective and Preventive Action" (CAPA).

Q19: What is the difference between a "Cold Room" and a "Stability Chamber"?

• Cold Room: Used for storage and distribution. It holds stock before it is sold.

• Stability Chamber: Used for R&D and Quality Control. It tests how drugs react over time at specific conditions (e.g., exactly 25°C / 60% RH). Stability chambers are much smaller and have extremely precise control (±0.5°C / ±3% RH).

Q20: What are "Phase Change Materials" (PCM) and are they used in cold rooms?

A: PCMs are materials that freeze/melt at specific temperatures (e.g., 5°C).
While mostly used in transport boxes (passive cooling), some advanced cold rooms use PCM tanks as a "Thermal Battery." If power fails, the PCM tank releases stored cold energy to keep the room cool for longer periods, acting as a non-electric backup.

Glossary of Terms

• HVAC: Heating, Ventilation, and Air Conditioning.

• NTC/PT100: Types of temperature sensors (Thermistors/Resistance Thermometers).

• BMS: Building Management System.

• Quarantine Area: A physically separated area (often a cage) inside the cold room for damaged, expired, or returned goods.

• Defrost Cycle: The periodic melting of ice off the evaporator coils. During this short time, air temperature may rise slightly, but product temperature should remain stable.