High Purity Water Systems for BioPharm颇尔’s high-purity water systems are designed to comply with international codes and regulations governing medicinal product manufacture referred to in various regional Pharmacopeia as, for example, USP, EP and JP.
These regulations specify standards of purity for a number of waters including Purified Water, Highly Purified Water, and Water For Injection.These waters are used in the preparation of compendial doseage forms in a variety of applications from bulk primary processing, media make up, equipment and container rinsing to use in final formulations.
Controls include microbial and total organic carbon (TOC) and in the latter cases, endotoxin.
Non-compendial water used in pharmaceutical processing must also meet specified criteria.This water may be used applied in early stages of synthesis or cleaning and as the feedwater to high purity water treatment systems.
Typically this water must meet at least potable(drinking water) standards and usually has additional limits specified (for example hardness, silica, total bacteria count).
右侧：Aria Microfiltration System
Left:USP 24-WFI System
PretreatmentRaw water supply varies in quality.Typical impurities which need to be reduced or controlled.
Pretreatment reduces the effect of potential variations in feedwater quality, minimizing the operating and maintenance requirements in the final treatment stages.
Typically it has little effect on some parameters indicative of final water quality such as anions, total bacteria count, TOC and volatile components but pretreatment must be effective to minimize plant operating costs.
- Micro organisms
- Dissolved gases
- Organic compounds
微滤Crossflow microfiltration (MF) is a highly efficient way to remove small suspended solids, large colloids, and micro-organisms from large volumes of water.
New generations of membranes in robust materials and large area format, which are unique to 颇尔, provide excellent economy and exceptionally stable performance independent of variability in feed water.Operating pressures are lower than UF (typically 1 to 2 bar) and the systems use backwash and air scrubbing techniques to minimize requirements for chemical regeneration.
- Removes turbidity, suspended solids, bioburden
- Reduces silt density index (SDI) to protect RO/NF and ion exchange
- Compatible with chlorine and other chemicals which may be present in feed
- Minimal waste stream
- Low operating cost
- Stable filtrate and low chemical compared to multimedia filters
超滤Ultrafiltration membranes, when incorporated in our systems, retain particles, bacteria, viruses, pyrogens (endotoxins), colloids and large organic molecules.Dissolved salts and smaller organic molecules pass freely through these systems.A wide variety of proprietary membranes are available to 颇尔, but the two most common applications for pharmaceutical water processing are in pretreatment (eg colloid removal) and for pyrogen control in both low and high temperature distribution using both hollow fiber and ceramic technologies.
Full process review and skilled design optimization mean that 颇尔 can apply UF in its systems with considerable advantages to end-users.
- Excellent protection when used in prefiltration
- Steam in place options available for pyrogen applications
- Sanitary and cleanable designs where required in final processing
Reverse OsmosisReverse osmosis (RO) is the finest level of membrane separation in liquids.The RO membranes used in 颇尔 systems act as an efficient barrier to all dissolved salts and inorganic molecules as well as most organic compounds (organics typically greater than 100 Daltons in molecular weight).
Water passes freely through, while salts are rejected typically from 98% to over 99%.
颇尔 has optimized the pretreatment, design and staging of RO systems in single or multipass arrangements for stable and low fouling performance and for extremely high recovery (water conversion) rates without the use of chemicals.
- Compact and modular design
- No added chemicals
- Very high rejection rates producing high purity filtrate
- Maximum efficiency in throughput
- Recovery rates as high as 95%
纳滤颇尔 also uses nanofiltration (NF) water technology with similar but slightly more open membranes than RO. The modules have higher unit capacity and lower operating pressures for greater economy where higher passage of monovalent ions and some small organics is not an important factor.
These systems are used typically to produce softened process water and for removal of high levels of common organic compounds found in some waters.
Other TechnologiesMembrane systems listed above can meet most requirements for process water, purified water and highly purified water or water for injection (WFI) quality.Some regulations still demand that WFI must be prepared using distillation.颇尔 systems can be used in parallel or in series with distillation and are often employed to take load off existing distillation installations.Distillation can be incorporated into systems when required.
Other important features of 颇尔’s high purity water systems include, according to process requirements, ozone dosing, ultraviolet (UV) treatment, carbon filters, ion exchange (softeners) and chemical dosing.颇尔’s own cartridge filters are also employed to protect tank vents, and as highly effective prefiltration or point-of-use guard filters.
Storage and DistributionTotal system design ensures that water is purified, stored and distributed with quality maintained to specification all the way.Tank designs take into account sizing, choice of material and microbiogical considerations.Additional components such as heat exchangers, filters, UV, ozone and point-of-use valves are selected on technical merit, simplicity, efficiency and cost effective maintenance.Loop pressure and flow rates are carefully designed and controlled to meet microbiological and safety considerations.
Microbiological ProtectionHigh quality water has to be properly handled and protected from contamination right up to point-of-use.The hydrophobic vent filters in 颇尔 systems provide high sterility assurance and generous air flow rates with minimum risk of blockage by wetting.Integrity testing of the filters is achieved with minimum fuss and maximum confidence.Final water quality at point-of-use is ensured by high flow rate, long life sterilizing grade filters capable of absolute removal of even the smallest organisms which may be encountered in practice.
颇尔 Advanced Separations Systems颇尔 Advanced Separations Systems (PASS) is an independent engineering and procurement entity for 颇尔’s global separations systems business.To successfully deliver high purity water systems that meet stringent customer requirements we have excellence in:
- Process System Design
- Systems Fabrication
- Project Management
PASS will provide the following:
- Installation Support
- Document Preparation
- Risk Analysis
- Operator Training
- After-Market Service