Case Study on Temperature Control system in a Pharmaceutical industry.

INTRODUCTION:

In the pharmaceutical industry, the temperature control processes range from research to production scale. To obtain high-quality reaction products, temperature control systems must reliably control the process sequence in an external reactor.

The environment inside a pharmacy and pharmaceutical storage areas must be optimal and constant to ensure the effectiveness of the medications within them. Temperature and relative humidity should be controlled, monitored and recorded, where relevant, to ensure compliance with requirements pertinent to the materials and products, and to provide a comfortable environment for the operator where necessary.

·      Maximum and minimum room temperatures and relative humidity should be appropriate.

·      Temperature conditions should be adjusted to suit the needs of the operators while wearing their protective clothing.

·      The operating band, or tolerance, between the acceptable minimum and maximum temperatures should not be made too close.

·      Cubicles, or suites, in which products requiring low humidity are processed, should have well-sealed walls and ceilings and should also be separated from adjacent areas with higher humidity by means of suitable airlocks.

·      Precautions should be taken to prevent moisture migration that increases the load on the HVAC system.

·      Humidity control should be achieved by removing moisture from the air, or adding moisture to the air, as relevant.

·      De-humidification (moisture removal) may be achieved by means of either refrigerated dehumidifiers or chemical dehumidifiers.

·      Appropriate cooling media for De-humidification such as low temperature chilled water/glycol mixture or refrigerant should be used.

·      Humidifiers should be avoided if possible as they may become a source of contamination (e.g. microbiological growth). Where humidification is required, this should be achieved by appropriate means such as the injection of steam into the air stream. A product-contamination assessment should be done to determine whether pure or clean steam is required for the purposes of humidification.

·      Where steam humidifiers are used, chemicals such as corrosion inhibitors or chelating agents, which could have a detrimental effect on the product, should not be added to the boiler system.

·      Humidification systems should be well drained. No condensate should accumulate in air-handling systems.

·      Other humidification appliances such as evaporative systems, atomizers and water mist sprays, should not be used because of the potential risk of microbial contamination.

·      Duct material in the vicinity of the humidifier should not add contaminants to air that will not be filtered downstream.

·      Air filters should not be installed immediately downstream of humidifiers.

·      Cold surfaces should be insulated to prevent condensation within the clean area or on air-handling components.

·      When specifying relative humidity, the associated temperature should also be specified.

·      Chemical driers using silica gel or lithium chloride are acceptable, provided that they do not become sources of contamination.

 

ANALYSIS:

Precision and accuracy are critical when deciding on a temperature control system for biomedical, industrial hemp, medical and pharmaceutical processing applications. To help manage an increasing demand, process heating and cooling equipment can be developed that regulates the temperature to ensure effective product control of blenders, extruders, fermenters, injection molding, mixers, reactors, sterilizers, tanks and vessels. To select the best temperature control system, follow these three key steps.

1 | Calculate System Size:

 Effective selection and sizing of the temperature control system can make a significant difference in reducing waste, achieving higher quality, increasing output, realizing faster heat up and cool down rates and improved profitability. Typical sizing questions include equipment ambient conditions, type, shape, dimensions and weight of the container, chemical mixture specific heat and weight per hour being treated, process temperatures, inlet/outlet quantity and size of lines, and control requirements. A safety factor should be included to allow for unknown or unexpected conditions. The size of the factor is dependent on the accuracy of the wattage calculation. Generally speaking, the smaller the system with fewer variables and outside influences, the smaller the safety factor. On the other hand, the larger the system and the greater the variables and outside influences, the greater the safety factor. Here are some general safety factor guidelines:

• 20% safety factor is the average

• 30% for larger systems with varying loads, cycle times, etc.

2 | Find the Right Fluid Liquid

Temperature control systems provide a uniform medium to transfer heat or cooling to a process. Liquid can circulate into areas that are challenging or ineffective by other means of temperature control like steam, cartridge heaters or other heating elements. Control accuracy within fractions of a degree is possible with the correct system and options selected. Compact and energy efficient designs allow for control of processes in limited spaces and offer reduced operating costs. Circulating liquid temperature control of your process can be handled through three (3) different mediums: water, water/glycol or heat transfer oil. The decision of which fluid type should be selected depends upon the temperature you are trying to achieve, heating and/or cooling loads, and process flow capabilities, cycle times, material, etc.

3 | Assess Control Features

The process control demands accuracy and reliability, while operators need easy-to-use, highly visible controls and indicating lights. Microprocessor based controls provide ultimate control performance and are configurable to meet specific application needs. These types of controls can greatly optimize your process. A variety of control features and communication options are available to ensure you are obtaining easily configured andb optimal results.

SOLUTIONS:

1.     High performance Thermostat:

Thermostats like LAUDA process thermostats from the Kryoheater Selecta (KHS) product line are synonymous with high-performance temperature control thermostating, long service life, ease of maintenance and intuitive operation. A two-stage compressor enables temperatures down to -60 °C. For temperatures down to -90 °C, a cascade cooling system with two cooling circuits is used. The condenser is cooled by means of cooling water and is regulated continuously and precisely by the injection control system. A step switch ensures energy-saving and low-wear partial load operation via automatic compressor control.

The Kryoheater Selecta product line consists of the two devices KHS 3560 W and KHS 2190 W, which can be used in chemical pharmaceutical production. They also perform impressively in simulations of the environmental conditions at inspection stations in the automotive and aerospace industry. The process thermostats are designed for pressurized operation with nitrogen. Benefits include the increase in maximum operating temperature and the extension in service life of the heat transfer liquids.

 

2.    Temperature control in the warehouse:
Pharma company maintains the temperature monitoring systems necessary to safely store and distribute pharmaceuticals through systematic qualification and validation process.

Qualification
To ensure a warehouse, cooler, or trailer is compliant, it is qualified with a mapping study that uncovers areas prone to fluctuations outside approved temperature ranges. To determine realistic performance, this qualification test is done first when empty and again when stocked with product.

Monitoring
Warehouse space must also be continuously validated with regular temperature monitoring. Monitoring takes two forms: proactive and reactive measures. Proactive measures, such as guard band monitoring systems with alarms that sound when temperatures approach a specific benchmark and consistent data reporting, help identify potential problems. Reactive measures involve an ability to react quickly to unexpected crises, such as equipment failures or extreme weather events. Creating reciprocal contingency plans with area partners and establishing internal procedures for moving product before it’s compromised are examples of reactive measures in a warehouse setting.

 

CONCLUSION:

Temperature monitoring and control is an essential part of any quality control program, especially when sensitive pharmaceuticals and biologic products are involved. With their access to industry-leading technology and professionals dedicated to mastering innovative ideas, Technicians can help companies master the intricacies of temperature control in pharmaceutical production and supply chains.