The pharmaceutical industry is one of the most heavily scrutinized industries around the world. Pharma manufacturers are needed to adhere to strict quality control while maintaining consistency in their products. All of this is made possible by cutting-edge and complex paraphernalia of pharmaceutical processing equipment with specialized functions.
It is the objective of every pharma and biopharma manufacturer to stay updated with the changing drug manufacturing landscape and evolve with time. Hence technology and innovation have been at the forefront of the most pharma operation with pharmaceutical processing equipment that reflects brilliant designs with customizable solutions tailored to specific and diverse needs.
Design & Quality Compliance Standards for Pharmaceutical Processing Equipment
While different pharma manufacturers have diverse clients that require customized solutions regarding pharmaceutical processing equipment, there are a few generally accepted design and compliance standards for pharmaceutical equipment qualification that manufacturers must adhere to. They may include the following:
Vessel Design
- ASME BPE 2016 for vessel and piping manufacturing
- ASME Section VIII, Div. 1 for pressure vessel manufacturing
Process Design
- US FDA 21 CFR 177.2600 for gaskets and O-rings
- ASME BPE 2016 for vessel and piping manufacturing
Electrical Design
- IEC 60529 standards for panel enclosure protection
- EN/IEC-60204 and UL 508 for electrical work
- CE Marking Compliance Testing and Certification
Different Pharmaceutical Processing Equipment for WFI & Other Sterile Products
WFI, or Water for Injection, is one of the purest forms of water that is widely used in pharma operations. The process of obtaining WFI includes distillation which not only gets rid of the pollutants in the water but also eliminates endotoxins, making it safe to be injected directly into the bloodstream of the patients.
Some of the pharma processing equipment needed for WFI or Sterile Injectables include the following:
- Manufacturing Vessel: These are the vessels required to charge the water for injection and adding APIs. They are often fitted with nitrogen sparging capabilities with oxygen flushing out to discourage microbial activity. After the process, the product is moved to the holding vessels using nitrogen blanketing and pumps.
- Holding & Storage Vessel: These are used to store sterile water and have a positive nitrogen pressure to prevent microbial growth. They are pre-sterilized with pure steam for sanitation purposes.
Vessels for Bio-Pharma Applications
Bio-pharma applications are designed for manufacturing therapeutic proteins, enzymes, hormones, antibiotics, alcohol, amino acids, and blood substitutes. The equipment used in bio-pharma manufacturing operations may include:
- Fermenters and bio-reactors to facilitate the growth of desired microbes and mammalian cells
- Process vessels for preparing medium, sterile feed, harvesting, lysing cells, preparing buffers, loading, and eluting chromatography, refolding, purifying, de-filtering, and storing samples.
CIP & SIP Pharmaceutical Process Equipment
Equipment for pharmaceutical manufacturing are cleaned and sanitised using the CIP and SIP processes without being moved from its location. CIP or Cleaning in Place normally includes different chemicals, heated water, and other agents to ensure that the equipment does not carry any contaminants that may interfere with the sanctity of the product being manufactured in them.
While on the other hand, SIP is referred to as Sterilization in Place or Steam in Place. It is an extension of CIP and is defined as the process in which hot steam is used to clean different parts of pharmaceutical manufacturing machinery and paraphernalia.
Some of the common equipment used in CIP and SIP processes include the following:
- Dosing systems to add desired substances to the water to remove impurities
- Tanks for process facilitation
- Pumps for circulation and proper pressure
- Recirculation skids
- Static or dynamic spray balls for thorough and consistent distribution of the cleaning or sterilizing agent
- Heat Exchangers with constant flow-through to meet heating and cooling needs
Treatment Vessels
As effluent water from pharmaceutical manufacturing operations can be a significant source of water pollution, pharma businesses are obligated to treat water in methods that lessen its negative environmental effects.
Numerous procedures that can be used to improve water quality in the pharmaceutical sector have been made possible by modern technological breakthroughs. There are also tried-and-true conventional procedures that are still in use. Different businesses apply various water treatments depending on the end product’s use case and the manufacturing facility’s capability
The treatment processes can be physical, chemical, or biological in nature and generally require the addition of chemicals or heat to inactivate the biowaste. Some of the most commonly used equipment for this process include bio-kill tank systems with varying degrees of automation.
Piping Networks
Process piping’s construction is essential to producing pharmaceuticals and biopharmaceuticals since it comes into contact with raw materials and finished products. In order to prevent cross-contamination from cell debris, media, residue from previous batches, and cleaning agents, the various pipe sizes and numerous bends along the piping path need to be thoroughly cleaned.
With adequate consideration for instruments, valves, and steam traps, CIP/SIP operations, drying, and pressure hold tests are often included into design considerations.
With decades of experience, TSA is equipped to cater to process requirements of varying specifications and scales. Our skilled design, engineering, and automation teams leverage their client-side experience to work directly with you, resulting in a tailored and sustainable solution that streamlines your procedures and ensures sterile integrity. Apart from serving a diverse need for pharmaceutical processing equipment, we also offer additional support, including validation documentation, clean room facilities, AMCs, and spares.
