Product Name:WATER FOR INJECTION GENERATION PLANT
Water For Injection Systems:
Regarding microbiological results,for water for injection,it is
expected that they be essentially sterile . Since sampling
frequently is performed in non-sterile areas and is not truly
aseptic occasional low level counts due to sampling errors may
occur.Agency policy ,is that less than 10CFU/100ML is an acceptable
action limit. None of the limits for water are pass/fail limits.
All limits are action limits . All liits are action limits .When
action limits are exceeded the firm must investigate the cause of
the porblem ,take action to correct the problem and assess the
impact of the microbial contamination of products manufactured with
water and document the result of their investigation .
What’s a multiple-effect Distiller?
● A multiple-effect distiller shall provide pyrogen-free,
water-for-injection (WFI) quality water for use in pharmaceutical
manufacturing.
● The system shall operate automatically and provide a “safe state”
in which likelihood of injury to personnel and damage to the unit
is minimized.
● In addition, it must be equipped with alarms and warnings in
order to guarantee and report product constant quality.
When to use multi-effect water distiller?
● Whenever the pharmaceutical manufacturer shall use high purity
water as stated in Pharmacopoeias.
● Whenever the amount of water required is higher than 100 l/h, the
use of multiple-effect configuration starts being more profitable.
● Whenever the water loop has to be maintained at 80ºC in order to
keep sterile conditions of the same.
Water For Injection System Standard:
| | USP | Ph.Eur. | ChP |
| TOC | ppm C | ≤ 0.50 | ≤ 0.50 | Same as Ph. Eur. |
| Conductivity | µS/cm | ≤ 1.3 (25°C) | ≤ 1.1 (20°C) | Same as Ph. Eur. |
| Nitrate (NO3) | | - | ≤ 0.2 ppm | ≤ 0.000006% |
| Aerobic bacteria | CFU/100 ml | ≤ 10 | ≤ 10 | Same as Ph. Eur. |
| Bacterial Endotoxins | /ml | ≤ 0.25 EU | ≤ 0.25 IU | ≤ 0.25 EUI |
FAQ:
1.Question:Which process do you adopt ?
Answer: Usually we will be according to what your raw water quality
and your requested water requirement .
2. Question: Can you customize For me?
Answer :Yes. We can manufacture according your requirement , we can
even design appearance of equipment .
3.Question: What standards is the Pharmaceutical Purified Water
System ?
Answer:Usually there are five standards in this pharmaceutical
industry , FDA,cGMP ,GMP ,USP, Japanese .
4.Question :How long is the Delivery time ?
Answer :Usually the delivery time is 35 -40 Days .
